AB Science: Masitinib Receives Orphan Drug Designation for the Treatment of ALS in Switzerland











Photo credit © AB Science


(Boursier.com) — AB Science SA announces that masitinib has received orphan drug designation (ODS) from the Swiss Institute for Therapeutic Products (Swissmedic) for the treatment of patients with amyotrophic lateral sclerosis (ALS).

This designation offers the promoter a series of incentive actions, including:
– the possibility of benefiting from a simplified authorization procedure (art.13) by Swissmedic
– a fee waiver, and
– an extended document protection period of 15 years.

Orphan drug designation in Switzerland is granted to products developed for the purpose of treating a fatal or chronically disabling disease which affects no more than 5 in 10,000 people in Switzerland, or whose active substance has been recognized as an important medicine for rare diseases in another country with equivalent drug control, as stipulated in Art. 13 TPA.

AB Science recalls that masitinib has already received orphan drug designation for ALS from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).


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