PI3K-delta inhibitors have often suffered from safety and tolerability issues, but Phase II data show higher efficacy and lower discontinuation rates for zandelisib than others in the class.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, including BioCryst's Orladeyo for the routine prevention of recurrent attacks of hereditary angioedema.

New treatments for congenital adrenal hyperplasia and relapsing forms of multiple sclerosis are among five drugs recommended for pan-EU approval this month. In addition, harmonized EU advice has been issued for Celltrion’s monoclonal antibody COVID-19 treatment.

Decisions are due on several EU marketing applications at the March meeting of the European Medicines Agency’s drug evaluation committee, the CHMP. Also, a number of companies might be asked to address outstanding issues the CHMP has about products they want to market that are near the final stages of review.