Eleven New Drugs Filed In EU; Sipavibart & Dorocubicel Win Fast-Track Status

AstraZeneca’s sipavibart for preventing COVID-19 in the highly vulnerable population of immunocompromised patients is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.

The EMA has started reviewing a new batch of drug marketing applications • Source: Shutterstock

The European Medicines Agency has begun fast-track reviews of the EU marketing applications for sipavibart, AstraZeneca’s drug for preventing COVID-19 in immunocompromised patients, and dorocubicel, ExCellThera’s treatment for patients with hematological malignancies who need a stem cell transplant.

The two investigational drugs are among 11 new entries on the EMA’s latest monthly list of products for which...