EMA Accepts First Diabetes Drug Onto PRIME
Hemophilia A Gene Therapy & DLBCL CAR-T Also Make The Grade
Provention Bio’s teplizumab, a potentially game-changing treatment for preventing or delaying type 1 diabetes, is one of three investigational products to be newly accepted onto the European Medicines Agency’s popular priority medicines scheme.
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Promising data from the likes of Provention Bio and Diamyd Medical suggest that treatment for the autoimmune disorder type 1 diabetes could soon move beyond insulin.
Just one of four accelerated assessment requests that were decided on at the European Medicines Agency this month is known to have been granted – for BioMarin’s Valrox. There was rejection for Amarin; Roche and Orchard are keeping the outcomes to themselves.
Shares in Provention Bio were pushed sharply higher on Monday after news that a two-week course of its experimental immunotherapy teplizumab dramatically reduced type 1 diabetes diagnosis rates in people at high risk for the disease.