Joanne Fagg

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.

Two of this year’s biggest FDA approval decisions are due next month, that of Astellas’s Zimura and Biogen/Sage’s zuranolone. The latter is filed in major depressive disorder and postpartum depression and is expected to be approved. Zuranolone is forecast to be Biogen's biggest growth driver but questions remain on its commercial prospects given its short two-week course of therapy.

Novartis and Roche’s Xolair has had a monopoly on the chronic spontaneous urticaria market for some time, but this is expected to change this year with the approval of Sanofi and Regeneron’s Dupixent for the skin disorder. And several late-stage projects are due to report clinical data in the next six to 12 months, including BTK inhibitors from Novartis and Sanofi. Amgen, Astrazeneca and the smaller players Allakos and Celldex are all also vying for a piece of the market.