U.S. health authorities have extended by three months their review of Astellas Pharma Inc's application for fungal drug Mycamine to be used for additional indications, the company said on Monday.
Mycamine, available on the U.S. market since May 2005, is currently used in blood stem cell transplants, which include bone marrow transplants, and to treat Candida fungal infections of the oesophagus.
Astellas has applied for it to also be used to treat other Candida infections, including candidemia where the yeast-like fungi infect the bloodstream.
Astellas said the extra time for the U.S. Food and Drug Administration review was needed to look at extra information submitted in response to FDA requests.
The news follows an announcement last week by Canadian firm Cardiome Pharma Corp and Astellas that FDA had extended by three months its review of a new drug to treat atrial fibrillation, an abnormal heart rhythm that lowers the heart's pumping capacity.