FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development / Commercial Operations

Prosensa Reclaims Rights to Drisapersen From GSK

Jan. 14, 2014

Dutch drugmaker Prosensa is taking back the rights to its drisapersen, a treatment for Duchenne muscular dystrophy (MD), from GlaxoSmithKline, ending the partners’ four-year collaboration.

The companies’ road to approval has been a rocky one, with a key Phase III clinical trial failing to show a consistent clinical benefit. Prosensa CEO Hans Schikan told Drug Daily Bulletin Monday the cause for the less-than-stellar results could be due to the fact that the trial was conducted in older boys with more advanced forms of the disease. He cited results from Phase I and II trials of younger boys as evidence that the drug may be more effective when begun earlier.

Duchenne MD, the most severe form of MD, has no FDA-approved treatment at the present time.

The companies plan to share their trial data with the scientific community in the near future. Meanwhile, Prosensa plans to continue investigating the potential benefits of drisapersen, Schikan said, adding that the company will likely have to undertake further clinical studies.

The FDA granted drisapersen breakthrough therapy designation in June 2013. The drug also has orphan drug status in the U.S., EU, Australia and Japan. — Lena Freund

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