Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
| Topics | Advisory Committee |
Date | Details | Biomedtracker Likelihood Of Approval 1 |
|
Sarepta Therapeutics' delandistrogene moxeparvovec for treatment of ambulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene |
Cellular, Tissue and Gene Therapies |
May 12 (teleconference) |
(Also see "Slim Adcomm Majority Boosts Sarepta’s Gene Therapy In Duchenne Muscular Dystrophy" - Pink Sheet, 12 May, 2023.) |
91%2 |
|
Pfizer's Abrysvo (respiratory syncytial virus vaccine) for prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals |
Vaccines and Related Biological Products |
May 18 (teleconference) |
(Also see "Pfizer’s RSV Vaccine: US FDA Panel Wants Robust Safety Program With Public Accountability" - Pink Sheet, 18 May, 2023.) |
99% |
|
Intercept Pharmaceuticals' obeticholic acid for the treatment of pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis |
Gastrointestinal Drugs |
May 19 (teleconference) |
(Also see "Intercept’s OCA Facing Extended Approval Wait In NASH As Known Risks Swamp Uncertain Benefits" - Pink Sheet, 19 May, 2023.) |
75%3 |
|
AstraZeneca's nirsevimab for prevention of respiratory syncytial virus lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season |
Antimicrobial Drugs |
June 8 (teleconference) |
99% | |
|
Confirmatory study conducted for Eisai's Leqembi (lecanemab) for treatment of early Alzheimer's disease |
Peripheral and Central Nervous System Drugs |
June 9 (teleconference) |
100% | |
|
Strain selection for updated COVID-19 vaccines for the 2023-2024 vaccination campaign |
Vaccines and Related Biological Products |
June 15 (teleconference) |
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|
Dosage optimization of new drug and biological products for pediatric patients with cancer |
Oncologic Drugs Pediatric Subcommittee |
June 16 (teleconference) |
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|
1 Biomedtracker LOA as of May 19, 2023 2 LOA up from 89% on May 11, 2023 3 LOA down from 85% on May 11, 2023 |
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