Swiss biopharmaceutical firm Basilea Pharmaceutica has received approval from the European Commission for its antifungal isavuconazole to treat adults with invasive aspergillosis and mucormycosis.
In Europe, isavuconazole will be marketed under the trade name Cresemba to treat these life-threatening fungal infections, which often occur in patients with cancer and other immunocompromised patients.
The company now plans to start a commercial launch of the drug in major European countries early next year.
Approval is based on results from the isavuconazole development programme, which included two Phase III trials, Secure and Vital.
Secure is a randomised, double-blind, active-control study in 516 patients with invasive aspergillosis, and Vital is an open-label non-comparative 146-patient study (ITT) to treat invasive aspergillosis patients with renal impairment, or invasive fungal disease (IFD).
The marketing authorisation for isavuconazole will be valid in all 28 European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway.
Earlier this year, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the regulatory approval of isavuconazole in the EU.
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."
Isavuconazole is being co-developed with Astellas Pharma, while Basilea has full global rights to the drug outside the US and Canada where Astellas is the exclusive licence holder.
In March, the US Food and Drug Administration (FDA) approved isavuconazole for patients 18 years of age and older to treat invasive aspergillosis and invasive mucormycosis.
