Pharmaceuticals Innovation & Drug Approvals Mar 2020

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Pharmaceuticals
Innovation (Extract)
Mar, 2020

2. Pharmaceuticals Innovation
Innovation trends very encouraging
• New drug filings increased from 64 in F2018 to 65 in F2019; new drug approvals declined from 53
to 45
• The first action approval rate decreased from 90% in FY18 to 79% in FY19
• Notably, since F2005 the top two years for new drug approvals are F2018 and F2019
• The industry needs to continue to enhance innovation in order to drive long-term revenue growth
- Significant innovation seen in specialty diseases, including cancer, virology, immune-related
disorders, and orphan drugs must continue
- High prices would be needed to generate significant sales – as therapies for specialized
populations are pursued

3. Pharmaceuticals
New drug filings increased from 64 in F2018 to 65 in F2019 while new drug approvals declined from 53 to 45
Source: FDA.gov, (Approval data as of Fiscal ending September 30), MS Research NHEA, IQVIA
FDA DRUG APPROVALS AND NEW DRUG APPLICATION (FILING) FIGURES

4. Pharmaceuticals
New drug filings increased from 64 in F2018 to 65 in F2019 while new drug approvals declined from 53 to 45
Source: FDA.gov, (Approval data as of Fiscal ending September 30), MS Research NHEA, IQVIA
Note: FDA's standard review clock is 12 months and priority review clock is 8 moths from the date of filing. Since the FDA date of filing acceptance is 60 days after filing, the approval clocks from the
date of acceptance are two months shorter than from the date of filing.
FDA DRUG APPROVALS AND NEW DRUG APPLICATION FIGURES (3Y ROLLING AVERAGE)

5. Pharmaceuticals
FDA new drug approvals FY2005–F2019 (through Sep. 30, 2019)
Source: FDA.gov (FDA New Drug Review presentation) - Approval data as of Fiscal ending September 30, MS Research NHEA, IQVIA

6. Pharmaceuticals
FDA first action approval rate FY1993–2018
Source: FDA.gov (FDA New Drug Review presentation) - Approval data as of Fiscal ending September 30, MS Research NHEA, IQVIA
CDER NME NDAS / BLAS: FIRST ACTION APPROVAL RATE BY FY

7. ACKNOWLEDGEMENT, THANKS, TERMS & CONDITIONS
We are indebted and grateful to various companies and sources that have been cited in the document for their data and insights. This report is not meant to be a substitute for
professional advice, and must not be relied upon as such without explicit, written consent. No representation or warranty (express or implied) is given as to the accuracy or completeness
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