Farxiga was the first SGLT2 inhibitor approved in the US and EU for treating type 2 diabetes. It received additional approvals for treating heart failure in 2020. Trulicity received expanded FDA approval for two additional doses (3.0 mg and 4.5 mg) based on trial results showing improved A1C reduction and weight loss compared to the 1.5 mg dose. SGLT2 inhibitors like Farxiga and GLP-1 agonists like Trulicity are effective diabetes treatments but are generally only recommended after other options due to costs and potential side effects. Novel dual-mechanism drugs in development may change standard treatment approaches.
This prsentation explains the use of biomarker with reference to an article: Accelerating Drug Develeopment using Biomarkers-Sitagliptin.
It was presented my my 2 friends and me. Hope it helps you guys.
This prsentation explains the use of biomarker with reference to an article: Accelerating Drug Develeopment using Biomarkers-Sitagliptin.
It was presented my my 2 friends and me. Hope it helps you guys.
Sitagliptin an oral anti-diabetic agentAmruta Vaidya
A concise presentation on the DPP-IV inhibitor Sitagliptin an oral anti-diabetic agent. Its general mechanism of action, pharmacokinetics, safety is included.
Dapagliflozin is an AstraZeneca patented medication. In India, Sun Pharma and Abbott serve as licensed partners for dapagliflozin's distribution. While the primary patent for dapagliflozin expired in October 2020, a specific (species) patent safeguards AstraZeneca's dapagliflozin in India until May 15, 2023.
Under the brand name "Oxra®," Sun Pharma will undertake the promotion and distribution of dapagliflozin. This medication is approved for use in the United States as a monotherapy and in combination therapy to enhance glycemic control in patients with type 2 diabetes.
In China, the National Medical Products Administration (NMPA) approved dapagliflozin, both in combination with metformin and as a standalone treatment, for inadequately-controlled type-2 diabetes mellitus. It was introduced for the treatment of type 2 diabetes in China in 2018.
Japan has authorized Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).
The Shanghai Shenkang Hospital Development Center has outlined a three-year plan to promote clinical skills and innovations in municipal hospitals, reflecting a commitment to healthcare advancements.
Efforts are being made to expand distribution channels across diverse geographical regions. AstraZeneca is closely monitoring the Indian market to secure a significant share and prevent the infringement of dapagliflozin by generic manufacturers.
Regulatory bodies are actively assessing dapagliflozin's drug and approval processes, ensuring compliance with appropriate dose and indication guidelines. For further inquiries, please contact pranayraju66@gmail.com.
This Presentation Give You A brief Information About DPP4 And New Recommendations .This Presentation Guide You How To Treat Patients With Safety.
For Further Contact:03354999496
Sitagliptin an oral anti-diabetic agentAmruta Vaidya
A concise presentation on the DPP-IV inhibitor Sitagliptin an oral anti-diabetic agent. Its general mechanism of action, pharmacokinetics, safety is included.
Dapagliflozin is an AstraZeneca patented medication. In India, Sun Pharma and Abbott serve as licensed partners for dapagliflozin's distribution. While the primary patent for dapagliflozin expired in October 2020, a specific (species) patent safeguards AstraZeneca's dapagliflozin in India until May 15, 2023.
Under the brand name "Oxra®," Sun Pharma will undertake the promotion and distribution of dapagliflozin. This medication is approved for use in the United States as a monotherapy and in combination therapy to enhance glycemic control in patients with type 2 diabetes.
In China, the National Medical Products Administration (NMPA) approved dapagliflozin, both in combination with metformin and as a standalone treatment, for inadequately-controlled type-2 diabetes mellitus. It was introduced for the treatment of type 2 diabetes in China in 2018.
Japan has authorized Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).
The Shanghai Shenkang Hospital Development Center has outlined a three-year plan to promote clinical skills and innovations in municipal hospitals, reflecting a commitment to healthcare advancements.
Efforts are being made to expand distribution channels across diverse geographical regions. AstraZeneca is closely monitoring the Indian market to secure a significant share and prevent the infringement of dapagliflozin by generic manufacturers.
Regulatory bodies are actively assessing dapagliflozin's drug and approval processes, ensuring compliance with appropriate dose and indication guidelines. For further inquiries, please contact pranayraju66@gmail.com.
This Presentation Give You A brief Information About DPP4 And New Recommendations .This Presentation Guide You How To Treat Patients With Safety.
For Further Contact:03354999496
List of GLP-1 Receptor Agonists for Diabetes & Weight Loss.pdfDoriaFang
The development of GLP-1 long-acting receptor agonists has become a research hotspot worldwide. There are 9 GLP-1RA hypoglycemic drugs have been approved for diabetes & weight loss.
Teneligliptin the next generation gliptinAKSHATA RAO
Teneligliptin , one of the emerging gliptins have established its prowess among the gliptin giants like Sitagliptin Vildagliptin and Linagliptin. Proven to be safe in renally compromised patients, this one is to watch out for.
A Little Bit of Everything, Quick & Snappy: Probiotics to Advances in the Car...PASaskatchewan
As pharmacists, you are rarely faced with a consistent patient population with similar problems and questions. More likely, each patient you interact with has unique and varied concerns that you must be ready to address in an instant. This session reflects the diversity of patients a pharmacist will face in day-to-day practice and covers a range of topics in a quick and snappy format. This session will cover the evidence as it relates to concurrent probiotic and antibiotic use, second line treatment for patients with type 2 diabetes, and explore new utilization strategies of using drugs traditionally used in the treatment of type 2 diabetes for patients with type 1 diabetes.
Tirzepatide is the new class of anti diabetic drug which was recently approved by US FDA.
It is the first drug which belongs to dual channel agonist. It is best medicine from compared to other diabetes drug
SGLT2 Inhibitors (Gliflozins): A New Class of Drugs to treat Type 2 Diabetes:Naina Mohamed, PhD
Sodium-Glucose Linked Transporter 2 (SGLT2) inhibitors such as Dapagliflozin (Farxiga), Canagliflozin (Invokana) and Empagliflozin (Jardiance) are a new class of oral drugs available to treat type 2 diabetes mellitus (Type 2 DM).
MFLN Nutrition and Wellness New Medications for Type 2 Diabetesmilfamln
Do your patients manage their diabetes by eating well and being active? Or do they need medication to help control their blood sugar? What medications are the most effective and what is new to the market? Tune in to this webinar to guide you through what is available and most effective to help your patients better control their type 2 diabetes.
Learning Objectives:
1. Understand the current paradigm for the treatment of type 2 diabetes.
2. Compare and contrast pros and cons of newer medications for the Treatment of type 2 diabetes.
3. Modify a treatment plan correctly and efficiently based on the side effect profiles of newer medications for the treatment of type 2 diabetes.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Explore our infographic on 'Essential Metrics for Palliative Care Management' which highlights key performance indicators crucial for enhancing the quality and efficiency of palliative care services.
This visual guide breaks down important metrics across four categories: Patient-Centered Metrics, Care Efficiency Metrics, Quality of Life Metrics, and Staff Metrics. Each section is designed to help healthcare professionals monitor and improve care delivery for patients facing serious illnesses. Understand how to implement these metrics in your palliative care practices for better outcomes and higher satisfaction levels.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
T2DM Therapeutic Area Landscape: SGLT2 and GLP1 (USA Market)
1. 1. Key Regulatory and Commercial Event Timelines for Farxiga (USA + EU)
2. Farxiga (dapagliflozin) was developed by BMS in partnership with AstraZeneca: First-in-class, Once-daily SGLT2
inhibitor approved for T2DM & HF treatment in USA & EU, whereas listed for T1DM in EU only
Jan-2007
ASZ/BMS Diabetes Alliance
(to co-develop & commercialize
Saxagliptin & Dapagliflozin)2
Jan-2014
Farxiga Approved in USA
for T2DM4
Nov-2012
Forxiga Approved in EU for
Type-II Diabetes3
May-2020
FDA Approves Farxiga to
Treat Heart Failure9
Oct-2020
EU Approves Forxiga to
Treat Heart Failure10
FARXIGA
Dec-2003
IND Application
Filed by BMS
(for Dapagliflozin)1
Saxagliptin & Dapagliflozin)2
Note: In USA market, ASZ has also given distribution right to Cardinal Health (NDC 55154-6932) and A-S Medication Solutions (NDC 50090-3481) for Farxiga brand
Dec-2010
NDA Filed for Farxiga for
Treatment of T2DM
(NDA202293)1
Dec-2013
ASZ Acquired BMS Diabetes
Business5
Jul-2013
Resubmit Dapagliflozin NDA (with
Long-term Data)4
Mar-2019
EU Approves Forxiga for Type-I Diabetes as an
Adjunct to Insulin6
Jul-2019
EU Approves to add Heart Claim Data on Forxiga
label in T2D7
Oct-2019
FDA Approves Farxiga to Reduce HF
Hospitalization Risk in T2DM Patients8
Sources: 1. FDA-IND 2. BMS-Annual Report 3. EMA-Forxiga 4. Drugs@FDA 5. ASZ Media 6. Forxiga D-I 7. EU-Heart Label 8. FDA- CVS Label 9. FDA-HF 10. EU-HF
ASZ – AstraZeneca, BMS – Bristol-Myers Squibb, IND – Investigation New Drug, NDA – New Drug Approval, T1DM – Type I Diabetes, T2DM – Type II Diabetes, HF – Heart Failure
4. Eli Lilly gets expanded FDA approval for two additional doses of its T2DM drug Trulicity
[03-Sept-2020] Eli Lilly has received approval from the US FDA for two additional doses of its T2DM drug Trulicity
(dulaglutide)1,3
The approval expands the label of
Once-Weekly Trulicity to include
3.0 mg & 4.5 mg doses based on data from
AWARD-11
The phase-III trial showed the additional
doses led to further benefits in A1C and
Results from AWARD-11
Randomized, Double-blind, Parallel-arm study [N=1842]
Trulicity 4.5mg Trulicity 3mg Trulicity 1.5mg
Reported significant A1C & weight reduction after 36-weeks
TRULICITY
Note: The AWARD-11 trial is currently being reviewed by EMA, and Lilly expects a recommendation decision on expanded doses in the EU by the end of 2020
Sources: 1. Eli Lilly Press Release 2. Trulicity Label Info 3. Drugs@FDA-Trulicity Suppl-36 4. Trulicity Website
doses led to further benefits in A1C and
Bodyweight Reduction when compared to
Trulicity 1.5 mg in people with T2DM
Primary Endpoint: Reduction in A1C
Secondary Endpoint: Weight Loss
Provides Better Glycemic Control in Long-term Management of T2DM
Availability of higher doses of Trulicity (4.5 mg or 3mg) offers powerful A1C reduction and weight loss in those group of
T2D patients whose diabetic condition was not controlled with current treatment. And it also helps HCPs to adjust the
different doses of Trulicity based on progressive diabetic conditions of patients.
Trulicity 4.5mg
-01.9% A1C
-10.4% Pound
Weight
Trulicity 3mg
-01.7% A1C
-08.8% Pound
Weight
Trulicity 1.5mg
-01.5% A1C
-06.8% Pound
Weight
5. 3. T2DM Therapeutic Area Landscape: SGLT2 and GLP1 (USA Market)
Note: IDF Diabetes Atlas
6. SGLT2 Inhibitors have been shown to be effective at lowering HbA1c levels, improving weight loss and
lowering blood pressure: used as monotherapy or in combination with other hyperglycemic agents
SODIUM-GLUCOSE COTRANSPORTER-2 (SGLT2) INHIBITORS
SGLT2 Inhibitors are newest class of oral-hyperglycemic
agents that have been FDA-approved for use with diet &
exercise to lower blood sugar in T2DM patients1,2
MoA: Prevents from reabsorbing glucose in kidney
SGLT2 is a glucose transporter
found in kidney: reabsorbs
90% of glucose and returns it
to the blood
SGLT2 Inhibitors prevent the
reabsorption of glucose that
Brand
Name
Generic Owner Compound Doses (mg) /
Frequency
Approval
Date
Invokana Canagliflozin J&J Small molecule 100 - 300
Once daily
Mar-2013
Farxiga Dapagliflozin ASZ/BMS Small molecule 5-10
Once daily
Jan-2014
Jardiance Empagliflozin BI Small molecule 1-25
Once daily
Aug-2014
Invokamet Canagliflozin +
Metformin
J&J Small molecule 50-150/500-
1000; BID
Aug-2014
Xigduo Dapagliflozin + ASZ/BMS Small molecule 5-10/500-1000 Oct-2014
List of current SGLT2 inhibitors: Approved by US-FDA2,3
Sources: 1. Journal of Diabetes Nursing-2019 2. Curr Opin Endocrinol Diabetes Obes.2018 3. J Investig Med High Impact Case Rep. 2017 4. Steglatro Label-Drugs@FDA
reabsorption of glucose that
has been filtered from renal
tubules
Clinical Benefits of SGLT2 Inhibitors1,2
• Effective HbA1c reduction
• Weight loss
• Small reduction in blood pressure
• Low risk of hypoglycemia
• CVS protection, benefits in heart failure
• Renoprotection (in diabetic nephropathy)
• Flexibility to use with others antidiabetics
• Once daily, oral agent
Xigduo Dapagliflozin +
Metformin
ASZ/BMS Small molecule 5-10/500-1000
Once daily
Oct-2014
Glyxambi Empagliflozin
+ Linagliptin
BI Small molecule 10-25/5
Once daily
Jan-2015
Synjardy Empagliflozin
+ Metformin
BI Small molecule 5-25/500-1000
BID
Aug-2015
Invokamet
XR
Canagliflozin +
Metformin
J&J Small molecule 50-150/500-
1000; BID
Aug-2014
Steglatro4 Ertugliflozin Merck Small molecule 5-15
Once daily
Dec-2017
04 SGLT2 Inhibitors are currently approved by the FDA for T2DM treatment:
Canagliflozin, Dapagliflozin, Empagliflozin, and most recently – Ertugliflozin
These drugs are administered orally once daily and given with or without food
7. GLP-1 agonists are a class of antidiabetic agents that mimic the actions of the glucagon-like peptide
GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONISTS
GLP-1 receptor agonists, also known as incretin-mimetics,
are agonists of the GLP-1 receptor. It has multiple
physiological effects that make it a great therapy option to
help improve glycemic control in T2DM patients1,2
MoA: Enhances glucose-dependent insulin secretion by
the pancreatic beta-cell, suppresses inappropriately
elevated glucagon secretion, and slows gastric emptying
Brand
Name
Generic Owner Duration of
Acton
Frequency Approval
Date
Rybelsus Semaglutide Nova
Nordisk
Short-acting 1st Oral GLP-1
Once daily
Sept-2019
Adlyxin Lixisenatide Sanofi Short-acting Once daily Jul-2016
Victoza Liraglutide Nova
Nordisk
Short-acting Once daily Jan-2010
Byetta Exenatide ASZ Short-acting Twice daily Apr-2005
List of current GLP-1 Agonists: Approved by US-FDA4,5
Sources: 1. Diabetes Spectrum-2017 2. Medscape-2020 3. BMJ Journal-2019 4. Diabetes Spectrum-2017 5. Diabetes, Metabolic Syndrome and Obesity-2016
Clinical Benefits of GLP-1 Agonist1,2,3
• Improvement in HbA1c levels
• Lower risk of causing hypoglycemia
• Beneficial in losing weight when used in
combination with diet & exercise
• Reduces biomarkers of CVS risks such as
C-reactive protein
Ozempic Semaglutide Nova
Nordisk
Long-acting Once weekly Dec-2017
Tanzeumi Albiglutide GSK Long-acting Once weekly Apr-2014
Trulicity Dulaglutide Eli Lily Long-acting Once weekly Sept-2014
Bydureon Exenatide QW ASZ Long-acting Once weekly Mar-2014
GLP-1 agonists are generally reserved for those who require two or more
antidiabetic agents in order to reach and maintain the goal HbA1c
Offers potent reduction in blood sugar level: average drop in A1c is 0.5 to 1.5%
8. Novel dual mechanism agents (such as SGLT1-SGLT2 Inhibitor and GLP-1/Glucagon Dual Agonist) have
emerged in late-phase trails that would change the existing treatment regimen for T2DM
T2DM PIPELINE OVERVIEW (USA MARKET)
P-III
Zynquista (sotagliflozin): Dual SGLT1-SGLT2 Inhibitor I Once-Daily Orally
Lexicon/Sanofi* *[Jul-19] End collaboration after mixed results in CKD
P-III
Bexagliflozin : SGLT2 Inhibitor I Once-Daily Orally
Theracos Inc.
P-I
YG1699 : Dual SGLT1-SGLT2 Inhibitor
Youngene Therapeutics Inc.
SGLT2
Inhibitors
Note: Q4 2019, BI has announced to initiate Phase 2 development of the GLP-1/glucagon dual agonist BI 456906
Sources: 1. Zynquista-NCTs 2. Bexagliflozin-NCTs 3. YG1699-NCT 4. Hanmi-NCTs
GLP-1
Agonists
P-III
ITCA 650 (Intarcia): Exenatide Implant I Twice-Yearly NDA
P-II
P-I
Efinopegdutide (Hanmi): GLP-1/Glucagon Dual Agonist I SC – Once Weekly
Cotadutide (AstraZeneca) I Once-weekly
GLP-1/Glucagon Dual Agonist
OPK-88003 (Opko Health) I Once-Weekly
GLP-1/Glucagon Dual Agonist
BI456906 (BI*) I Once-weekly
GLP-1/Glucagon Dual Agonist
LY3305677 (Eli Lilly)
GLP-1/Glucagon Dual Agonist
9. Guideline recommendations based on CVS and renal benefits of SGLT2 inhibitors and GLP-1 agonists plays
a pivot role for high adoption of these novel therapies in most of T2DM patients
T2DM MARKET TRENDS: SGLT2 INHIBITORS + GLP-1 AGONITS
Current Dynamics Opportunity/ Strength
Generic therapies such as
Sulfonylurea and Thiazolidines are
used in early-treatment, both in
combination with Metformin and as
monotherapy
Branded oral therapies (DPP-4 &
CV & CKD benefits seen with SGLT2
inhibitors and GLP-1 agonists are likely
to drive the market in T2DM patients
with co-morbidities
High prevalence of obesity in T2DM
patients favour the use of SGLT2
Threat/ Weakness
More expensive than oral anti-
diabetes
SGLT2 inhibitors and GLP-1
agonists are generally not
recommended as 1st Line
treatment , and also have black-
Branded oral therapies (DPP-4 &
SGLT2 inhibitors) and injected
therapy (GLP-1 agonists) are typically
added on to generics after failure of
monotherapy
patients favour the use of SGLT2
inhibitors and GLP-1 agonists – shown
to induce significant weight loss
Oral Rybelsus is likely to expand usage
to earlier lines of therapy, taking high
share from other oral drugs
Longer-acting drugs such as ITCA-650
Exenatide implants (yearly or twice-a-
year) may shift the current treatment
paradigm
treatment , and also have black-
box warnings on label
Growth of biosimilar insulins
Tighter controls by
payers/regulatory bodies (such
as mandatory rebates or
discounts on drug prices)