March 24, 2020

Impact: Moderate

FDA has announced that it will postpone or cancel all non-essential meetings through April 30, 2020 due to COVID-19. The following meetings are affected:

  • April 21, 2020: FDA Pulmonary-Allergy Drugs AdCom to discuss Trelegy Ellipta sNDA for IMPACT trial results (GlaxoSmithKline).
  • April 22, 2020: FDA AdCom (undetermined) to discuss sNDA for OCA (Ocaliva) in liver fibrosis due to NASH (Intercept).
  • April 23, 2020: FDA imaging Drugs AdCom to discuss NDA for flortaucipir F18, radioactive diagnostic agent for Alzheimer’s disease (Ely Lilly).

Although the FDA didn’t specifically comment on drug approval reviews, these PDUFA dates may be missed:

  • March 25, 2020: PDUFA date for resubmitted NDA of ozanimod in relapsing multiple sclerosis (Bristol Myers Squibb).
  • March 26, 2020: PFUDA date for rizaport versafilm for acute migraine (IntelGenx Technologies)
  • Mar 28, 2020: PDUFA date for NDA of Triferic IV formulation as iron replacement/maintenance therapy in chronic kidney disease patients on dialysis (Rockwall Medical).
  • April 4, 2020: PDUFA date for BLA of luspatercept in treatment of anemia in transfusion-dependent patients with VL/Int-1 risk ring sideroblast positive myelodysplastic syndrome (Bristol-Myers Squibb and Acceleron Pharma).
  • April 25, 2020: PDUFA date for BLA of MenQuadfi, a meningococcal vaccine (Sanofi).
  • April 26, 2020: PDUFA date for NDA of opicapone for once-daily adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes (Neurocrine).
  • April 30, 2020: PDUFA date for BLA of isatuximab in combination with Pomalyst and dexamethasone in multiple myeloma (Sanofi).