Asahi Kasei Pharma obtains approval to manufacture and sell Cresemba™ Capsule 100 mg and Cresemba™ Intravenous Infusion 200 mg in Japan
December 23, 2022
Asahi Kasei Pharma Corp.
Asahi Kasei Pharma today obtained approval to manufacture and sell Cresemba™ Capsule 100 mg and Cresemba™ Intravenous Infusion 200 mg (generic name: isavuconazonium sulfate, development code: AK1820) in Japan for treatment of the fungal infections of aspergillosis, mucormycosis, and cryptococcosis.
Isavuconazonium sulfate was created as a new antifungal agent by Basilea Pharmaceutica International Ltd, Allschwil (Basilea) of Switzerland. Asahi Kasei Pharma obtained exclusive rights to develop and commercialize isavuconazonium sulfate in Japan in September 2016, and after advancing its development, applied for approval to manufacture and sell it in Japan in September 2021.
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 isavuconazonium sulfate as a new therapeutic solution for patients with fungal infections.
Product overview of Cresemba™
- Product name
- Cresemba™ Capsule 100 mg, Cresemba™ Intravenous Infusion 200 mg
- Generic name
- Isavuconazonium sulfate
- Indication
- The following fungal infections:
- Aspergillosis (invasive aspergillosis, chronic progressive pulmonary aspergillosis, simple pulmonary aspergilloma)
- Mucormycosis
- Cryptococcosis (pulmonary cryptococcosis, disseminated cryptococcosis (including cryptococcal meningitis))
- Dosage and administration
- Cresemba™ Capsule 100 mg
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.
Cresemba™ Intravenous Infusion 200 mg
For adults, ordinarily 6 doses of 200 mg of isavuconazole intravenously, once every 8 hours, each dose administered over a period of at least 1 hour. Starting 12 to 24 hours after the 6th dose, 200 mg of isavuconazole intravenously once per day, each dose administered over a period of at least 1 hour.
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 and fungal infections. Established as a subsidiary of Basilea Pharmaceutica Ltd. in 2008.