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Rhythm’s Setmelanotide Loses Fast-Track Status In Europe

Product Reverts To Standard Review; US Approval Decision Due This Month

 
• By Maureen Kenny

The loss of fast-track status for setmelanotide at the European Medicines Agency means the review of the potential treatment of two rare genetic disorders of obesity will take longer than Rhythm Pharmaceuticals had originally hoped.

Background concept wordcloud illustration of obesity fat overweight
Many patients with severe obesity experience debilitating comorbidities • Source: Shutterstock

Rhythm Pharmaceuticals, Inc.’s setmelanotide has lost its accelerated assessment status at the European Medicines Agency, meaning the marketing authorization application (MAA) for the potential treatment of two rare genetic disorders of obesity is now being reviewed under standard timelines. The company has not given an explanation for the change.

In the US, another market where the investigational melanocortin-4 receptor (MC4R) agonist is under evaluation, an approval decision following priority...

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