Basilea's antifungal Cresemba® (isavuconazole) launched in France - Seite 2

Professor Jean-Pierre Gangneux added: "There are gaps in the spectrum of various currently available antifungal drugs. Isavuconazole is characterized by a broad spectrum with activity against filamentous fungi such as Aspergillus spp. and Mucorales."

About Cresemba (isavuconazole)

Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.¹ In Europe, isavuconazole received marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.² Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea is marketing isavuconazole as Cresemba in Germany, Italy, the UK, France and Austria and is seeking national pricing and reimbursement in additional EU countries. In the US, the drug is marketed by Basilea's license partner Astellas Pharma US. Outside the US and the EU, isavuconazole is currently not approved for commercial use. The European marketing authorization is valid in all 28 European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway.

About the isavuconazole invasive aspergillosis and mucormycosis studies

The approval of Cresemba is based on results from the isavuconazole development program. The safety and efficacy profile of isavuconazole in adult patients with invasive aspergillosis was demonstrated based on data from two phase 3 clinical studies: SECURE, a randomized, double-blind, active-control study in 516 patients (intent-to-treat population, ITT) with invasive aspergillosis, and VITAL, an open-label non-comparative 146-patient study (ITT) of isavuconazole in the treatment of invasive aspergillosis patients with renal impairment, or invasive fungal disease (IFD) caused by emerging molds, yeasts or dimorphic fungi, including invasive mucormycosis.

In the SECURE study, isavuconazole was non-inferior to voriconazole based on the primary endpoint of all-cause mortality at Day 42 in the intent-to-treat population. All-cause mortality through Day 42 was 19% in the isavuconazole treatment group and 20% in the voriconazole treatment group.³

In the SECURE study, similar rates of non-fatal adverse events were observed for isavuconazole and the comparator, voriconazole. Further, the percentage of study drug-related adverse events in invasive aspergillosis patients was 42% for isavuconazole and 60% for voriconazole. In addition, the percentage of treatment-emergent adverse events in the system organ classes of hepatobiliary disorders was 9% for isavuconazole versus 16% for voriconazole; skin or subcutaneous tissue disorders was 33% for isavuconazole versus 42% for voriconazole; and eye disorders was 15% for isavuconazole versus 27% for voriconazole.³