(AOF) – 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). As a reminder, masitinib has already received orphan drug designation for ALS from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
This designation offers the sponsor a series of incentives, including the possibility of benefiting from a simplified authorization procedure (art.13) by Swissmedic, a waiver of fees, 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.
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Loss of speed in European research
European research is losing ground to American and Chinese research. In twenty years, Europe’s share has fallen from 41% to 31% in global R&D. China’s share jumped from 1% to 8%. As for the United States, which supplanted Europe, in 2001 it devoted only 2 billion euros per year more than Europe to R&D, whereas now this gap has reached 25 billion! Some experts accuse the European authorities of not having deployed effective policies. The financing of pharmaceutical research should therefore have been better targeted via the “Horizon 2020” programme. France only comes in eighteenth position in European funding despite the quality of its research. Conversely, the United States concentrates funding on Boston and a few centers of excellence.