Update for January 12, 2023

Regulatory Update
 
The FDA approved lecanemab (Leqembi, Eisai & Biogen), on 1/6/2023, too slow the reduction in cognition in Alzheimer’s patients with mild cognitive impairment or mild dementia. Eisai & Biogen set WAC for at lecanemab $26,500 per year.
 
The FDA accepted the BLA for nirsevimab for the prevention of respiratory syncytial virus (RSV) in newborns and infants with an approval decision anticipated in 3Q23.
 
The FDA accepted the BLA for rozanolixizumab for the treatment of generalized myasthenia gravis in patients who are anti-acetycholine receptor or anti-muscle-specific tyrosine kinase antibody positive with an approval decision expected by the end of 2Q23
 
The FDA accepted the BLA for glofitamab for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy and set a PDUFA date for 7/1/2023.
 
The FDA accepted the NDA for vamorolone for the treatment of Duchenne muscular dystrophy (DMD) and set a PDUFA date for 10/26/2023.
 
The FDA has placed a hold on the launch of vonoprazan until acceptable levels of nitrosamine and met and maintained throughout the shelf-life of the product.
 
Checkpoint Therapeutics submitted a BLA for cosibelimab for the treatment of metastatic cutaneous squamous cell carcinoma.
 
Novan submitted an NDA for berdazimer gel for the treatment of molluscum contagiosum.
 
The FDA granted an Orphan Drug Designation to azeliragon for the treatment of glioblastoma.