The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending Orphan Drug designation for Rhythm Pharmaceuticals’ (RYTM -1.2%) setmelanotide for the potential treatment of Bardet-Biedl syndrome, a rare genetic disorder characterized by obesity, visual impairment, learning disabilities and kidney malfunction.
Among the benefits of Orphan Drug status in Europe is a 10-year period of market exclusivity for the indication, if approved.
A final decision from the European Commission usually takes ~60 days.
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