Asahi Kasei Pharma files application for approval to manufacture and sell Cresemba™ Capsule 40 mg as additional formulation in Japan
September 29, 2023
Asahi Kasei Pharma Corp.
Asahi Kasei Pharma today filed an application for approval to manufacture and sell Cresemba™ Capsule 40 mg [planned] (generic name: isavuconazonium sulfate, "the product") as a new formulation in Japan for the treatment of invasive fungal infections.
The product is an additional formulation of Cresemba™ Capsule 100 mg and Cresemba™ Intravenous Infusion 200 mg, which Asahi Kasei Pharma has sold in Japan since April 2023. Isavuconazonium sulfate was created as a new antifungal agent by Basilea Pharmaceutica International Ltd, Allschwil (Basilea) of Switzerland, from which in September 2016 Asahi Kasei Pharma obtained exclusive rights to develop and commercialize in Japan.
Expected to have efficacy and safety equivalent to Cresemba™ Capsule 100 mg, the product has a smaller capsule size which is easier to swallow. Asahi Kasei Pharma hopes to further contribute to patients with invasive fungal infections by adding the product as a therapeutic option that can improve convenience and adherence to medication for patients.
In accordance with its mission “to sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science,” Asahi Kasei Pharma aims to realize a society where “no one should have to give up doing what they love due to illness” by providing the product as a new therapeutic solution for patients with fungal infections.
Product overview
- Product name
- Cresemba™ Capsule 40 mg [planned]
- Generic name
- Isavuconazonium sulfate
- Indication
- The following fungal infections [planned]:
• Aspergillosis (invasive aspergillosis, chronic progressive pulmonary aspergillosis, simple pulmonary aspergilloma)
• Mucormycosis
• Cryptococcosis (pulmonary cryptococcosis, disseminated cryptococcosis (including cryptococcal meningitis)) - Dosage and administration
- For adults, ordinarily 6 doses of 200 mg of isavuconazole orally, once every 8 hours. Starting 12 to 24 hours after the 6th dose, 200 mg of isavuconazole orally once per day. [planned]
About Basilea
- Company name
- Basilea Pharmaceutica International Ltd, Allschwil
- Headquarters
- Allschwil, Switzerland
- CEO
- David Veitch
- Businesses
- Development and commercialization of innovative drugs to meet medical needs of patients with severe bacterial or fungal infections. Established as a subsidiary of Basilea Pharmaceutica Ltd. in 2008.