Basilea Pharma: Astellas Pharma Gets FDA Approval For Cresemba's Expanded Use In Kids With IA, IM

(RTTNews) - Switzerland's Basilea Pharmaceutica Ltd. announced Monday that its license partner Astellas Pharma US, Inc. (ALPMY, ALPMY) received the US Food and Drug Administration approval for expanded use of antifungal Cresemba (isavuconazole) in children with invasive aspergillosis or IA and invasive mucormycosis or IM.

The FDA also granted pediatric exclusivity for Cresemba, which extends the period of market exclusivity for Cresemba in the United States by an additional six months to September 2027.

The commercial-stage biopharmaceutical company focused on severe bacterial and fungal infections noted that Cresemba for injection is approved for adults and now for pediatric patients 1 year of age and older.

Cresemba capsules are approved for adults and now for pediatric patients 6 years of age and older, who weigh 16 kilograms and greater.

Isavuconazole, is an intravenous and oral azole antifungal, commercialized under the trade name Cresemba. Basilea has entered into several license and distribution deals for isavuconazole covering around 115 countries.

The latest approval is based on results from two pediatric clinical studies, including a phase 2 open label, non-comparative, multicenter study evaluating the safety, efficacy and pharmacokinetics of Cresemba for the treatment of IA and IM in pediatric patients aged 1 to 17 years old.

In Europe, Basilea submitted a similar application for a pediatric label extension of Cresemba in August 2023, which is currently under assessment by the European Medicines Agency. The company anticipates a decision by the European Commission in the first half of 2024.

Upon completion of the regulatory procedure, Cresemba would be eligible to an additional two years of market exclusivity in the European Union, until October 2027.

At present, Cresemba is approved in 76 countries, and is currently marketed in 71 countries, including the United States, and most EU member states.

Marc Engelhardt, Chief Medical Officer of Basilea, said, "These severe mold infections primarily affect children suffering from hematologic malignancies, or other immunodeficiency disorders and there is a high unmet medical need for new antifungal treatment options in the pediatric population. We are pleased that access to Cresemba is now available to this vulnerable patient population."

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