The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended Basilea's Cresemba - which is marketed by Astellas in the US - for the treatment of rare fungal infections.
The drug treats patients with invasive aspergillosis or mucormycosis, life-threatening infections that mostly occur in people with compromised immune systems, such as caner patients.
The European Commission will now review the CHMP’s positive opinion on Cresemba (isavuconazole) and make a final decision in the coming months.
The drug will face competition from Pfizer’s Vfend (voriconazole). In the Phase III SECURE trials that the recommendation was based on, Cresemba was non-inferior to Vfend in all-cause mortality in patients with invasive aspergillosis.
The EU recommendation follows the drugs approval by the FDA in March. This allowed Basilea to receive a milestone payment of 30 million Swiss francs from Astellas. Cresemba also received Orphan Drug and Qualified Infectious Disease Product designation from the US regulator, giving it priority review and five years extra of market exclusivity.