EC approves Basilea's isavuconazole to treat invasive aspergillosis and mucormycosis
The European Commission (EC) has approved Basilea Pharmaceutica's isavuconazole (Cresemba) product to treat invasive aspergillosis and mucormycosis.
The company plans to start a commercial launch of the drug in major European countries in early next year.
Earlier this year, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the regulatory approval of isavuconazole in the European Union (EU) for the treatment in adults with invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate.
The marketing authorization for isavuconazole will be valid in all 28 EU member states, as well as in Iceland, Liechtenstein and Norway.
Isavuconazole is an intravenous and oral broad-spectrum antifungal used to treat invasive fungal infections, which occur mostly in immunocompromised patients such as cancer patients undergoing chemotherapy.
Basilea Pharmaceutica CEO Ronald Scott said: "The European approval of Cresemba for the treatment of invasive aspergillosis and mucormycosis is a key milestone for Basilea.
"It provides us with the unique opportunity to launch Cresemba as our second hospital anti-infective in Europe and offers an important new therapeutic option to healthcare professionals and their patients suffering from these life-threatening fungal infections."
The US Food and Drug Administration has already approved isavuconazole for patients 18 years of age and older to treat invasive aspergillosis and invasive mucormycosis.
Outside the US, isavuconazole is an investigational product and currently not approved for commercial use.
PBR Staff Writer
Published 19 October 2015Source: http://regulatoryaffairs.pharmaceutical-business-review.com/
