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news.The European Medicines Agency (EMA) has accepted to review Basilea Pharmaceutica’s isavuconazole marketing authorization application (MAA) for the treatment of invasive aspergillosis and mucormycosis (zygomycosis) in adults.
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Scheduled to reviewed by EMA under the centralized marketing authorization procedure, the application, if approved, would eanble the company to market isavuconazole in all 28 European Union member states, as well as in Iceland, Liechtenstein and Norway.
Basilea chief executive officer Ronald Scott said: "This is an important milestone in the development of isavuconazole.
"Based on its profile, isavuconazole could potentially play an important role in the treatment of life-threatening invasive mold infections."
Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal for the treatment of life-threatening invasive fungal infections that occur in immunocompromised patients, such as cancer patients undergoing chemotherapy.
The drug secured the US Food and Drug Administration (FDA) fast-track status and is also designated a qualified infectious disease product (QIDP) for invasive aspergillosis, mucormycosis and candidiasis under the US GAIN Act.
A US New Drug Application (NDA) seeking isavuconazole approval for the treatment of invasive aspergillosis and mucormycosis was also submitted by Basilea’s co-development partner Astellas Pharma in July.