AB Science SA , a pharmaceutical company, announces that masitinib has been granted orphan drug status (ODS) by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of patients with amyotrophic lateral sclerosis (ALS).
As a reminder, masitinib has previously received ODS for ALS from the US Food and Drug Administration (FDA) and from the European Medicines Agency (EMA).
This designation provides the sponsor with a series of incentives, including: the possibility of a simplified authorization procedure (Art.13) by Swissmedic; fee waivers, and extended document protection period of 15 years.
Orphan drug designation in Switzerland is given to compounds that are developed for the treatment of a life-threatening or chronically disabling disease that affects no more than 5 out of 10,000 persons in Switzerland, or its active substance has been recognized as an important medicinal product for rare diseases in another country with equivalent medicinal product control as stipulated in Art. 13 TPA.
Professor Olivier Hermine, president of the scientific committee of AB Science and member of the Acad
