US FDA approval and panel tracker: July 2023

Eisai and Biogen’s Leqembi received full approval to treat Alzheimer’s disease last month. That was expected; what was not was that the label came with a boxed warning over Aria, a brain swelling disorder, with recommendation for ApoE4 genetic testing to assess Aria risk. Leqembi’s launch is under way with Biogen highlighting on its quarterly call that it has Medicaid coverage in 48 states so far. Elsewhere good news finally came for Verrica’s Ycanth after three previous complete response letters. This is the first FDA-approved therapy to treat molluscum contagiosum, a viral condition that creates a localised skin infection. There was also good news for Astrazeneca and Sanofi’s Beyfortus, an antibody to prevent respiratory syncytial virus (RSV) in young children. Sanofi noted on its second-quarter call that it is confident of a broad recommendation at the ACIP meeting on 3 August, and will price the therapy like a premium vaccine. Hot on its heels is Pfizer’s Abrysvo, due a Pdufa decision as a maternal RSV vaccine later this month.