Burton-based pharmaceutical and services giant Clinigen Group and Basilea Pharmaceutica International, a Swiss pharmaceutical company focused on providing innovative pharmaceutical hospital products, have initiated a Managed Access program for isavuconazole to treat patients with invasive fungal infections in those European countries where isavuconazole has been approved but is not yet commercially available.
Isavuconazole is an intravenous and oral triazole antifungal indicated for the treatment of adult patients with invasive aspergillosis and adult patients with mucormycosis for whom amphotericin B is inappropriate.
Isavuconazole received U.S FDA approval in March 2015 and European Marketing Authorisation in October 2015, and is commercially available in the U.S and in certain key European Union (EU) countries, including Germany and the UK. Isavuconazole is not yet commercially available in all EU countries. Outside the U.S and EU, isavuconazole is an investigational product not approved for commercial use.
The access program will be run by Clinigen’s Idis Managed Access (MA) division and will enable patients with serious fungal infections in those EU states where isavuconazole is not yet commercially available as well as Iceland, Liechtenstein and Norway, to access isavuconazole via their physician.
Access to isavuconazole will be provided by Idis MA following a physician request for individual patients who meet the established eligibility criteria.
Steve Glass, group managing director of Clinigen, said: “Invasive fungal infections pose a fatal threat to immuno-compromised patients. It is therefore crucial that new treatment options like isavuconazole are made available and can be accessed by those who need it at the first possible opportunity. As partners to Basilea, Idis MA will leverage its European distribution network and regulatory expertise to deliver this important medicine to individual patients, wherever they are located in Europe”.