- A committee of the European Medicines Agency (EMA) recommended the expanded approval of Rhythm Pharmaceuticals' ( NASDAQ: RYTM ) Imcivree (setmelanotide) to include the treatment of obesity and control of hunger in patients six years of age and older with genetically confirmed Bardet-Biedl syndrome (BBS).
- The European Commission (EC) will make a final decision on the positive opinion issued by the EMA's Committee for Medicinal Products for Human Use.
- The EC is expected to make a decision in Q4, the company said in a July 22 press release.
- BBS is a genetic condition that impacts multiple body systems. Besides insatiable hunger and obesity, the disorder can also cause cognitive impairment, kidney dysfunction and visual impairment, among other things.
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Rhythm's obesity therapy Imcivree gets EMA panel nod for expanded use