At least 11 PDUFA dates on deck in April

At least 11 PDUFA dates are on the calendar in April. Six of the applications are for new medicines, four seek label expansions and one covers a generic formulation. 

Last week, an FDA advisory committee unanimously voted in favor of accelerated approval of tofersen to treat SOD1-mutant amyotrophic lateral sclerosis based on the biomarker NfL, which is being proposed as a new surrogate endpoint for the indication. An approval would not only usher in NfL as an endpoint, but also make tofersen, an antisense therapy from Biogen Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS), the first treatment specifically authorized for the SOD1 form of ALS...