Announcement of listing on the NHI drug price standard and marketing of Cresemba™ Capsule 100 mg and Cresemba™ Intravenous Infusion 200 mg in Japan
March 15, 2023
Asahi Kasei Pharma Corp.
Asahi Kasei Pharma announces that Cresemba™ Capsule 100 mg and Cresemba™ Intravenous Infusion 200 mg (generic name: isavuconazonium sulfate, development code: AK1820) for the treatment of invasive fungal infections have been listed on Japan's National Health Insurance (NHI) drug price standard today. The market launch of the products is scheduled for April 6, 2023.
Isavuconazonium sulfate was created as a new antifungal agent by Basilea Pharmaceutica International Ltd, Allschwil (Basilea) of Switzerland. It was approved in the U.S. and Europe in 2015, and has currently been approved in approximately 70 countries around the world. Asahi Kasei Pharma obtained exclusive rights to develop and commercialize isavuconazonium sulfate in Japan in September 2016, and after advancing its development, obtained approval to manufacture and sell Cresemba™ in Japan in December 2022.
As invasive fungal infections often cause severe symptoms, early treatment is said to be particularly important, with any delay significantly affecting patient outcome. Asahi Kasei Pharma looks forward to providing isavuconazonium sulfate for the treatment of invasive fungal infections.
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. - Manufacture and sale
- Asahi Kasei Pharma
- Approval
- December 23, 2022
- NHI price listing
- March 15, 2023
- Launch of sale
- April 6, 2023 (scheduled)
- NHI prices
- ¥4,505.70 for Cresemba™ Capsule 100 mg
¥27,924 for Cresemba™ Intravenous Infusion 200 mg
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.