Allschwil, Switzerland, December 11, 2023
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that its license partner Astellas Pharma US, Inc. (“Astellas”) received the approval of Cresemba® (isavuconazole) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients by the US Food and Drug Administration (FDA). 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.
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We congratulate Astellas on the approval of Cresemba for the use in children who suffer from invasive aspergillosis or mucormycosis. 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.”
The 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 addition, the FDA 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.
In Europe, Basilea submitted a similar application for a pediatric label extension of Cresemba in August 2023. This application is currently under assessment by the European Medicines Agency (EMA). Basilea anticipates a decision by the European Commission in the first half of 2024. Upon completion of this regulatory procedure, Cresemba would be eligible to an additional two years of market exclusivity in the European Union, until October 2027.
Cresemba is approved in 76 countries to date and is currently marketed in 71 countries, including the United States, most EU member states and additional countries inside and outside of Europe. According to the latest available market data, total global in-market sales of Cresemba in the twelve months between July 2022 and June 2023 amounted to USD 421 million, a 19 percent growth year-on-year. […]
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