EMA Considers Fast-Tracking Rhythm’s Insatiable Hunger & Obesity Disorders Drug
Setmelanotide, which is being developed to treat insatiable hunger and early-onset severe obesity in people with rare genetic disorders, was also recently submitted to the US regulator for approval.
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Drug already approved for multiple rare genetic disorders of obesity shows significant weight-loss reduction in Bardet-Beidl syndrome, but not in the smaller indication of Alström syndrome.
The European Medicines Agency has agreed to fast track the review of four marketing applications in recent months.The products include AstraZeneca's advanced breast cancer treatment, Enhertu, two investigational CAR-T therapies, and a potential treatment for rare genetic disorders of obesity.
Alnylam and Eiger join the select group of companies whose products have been granted fast-track status at the European Medicines Agency