Rhythm gets second OK for genetic obesity drug Imcivree, swings into royalty deal
Another OK, another 2,000 potential patients.
On Thursday, Rhythm Pharmaceuticals received its second FDA green light for its obesity management drug for those with ultra-rare genetic diseases, this time for Bardet-Biedl syndrome, a disease that impacts a number of organs but with early-onset obesity as a major symptom. And the company also engineered a royalty deal netting it up to $100 million.
The FDA approved the drug, known as setmelanotide and marketed as Imcivree, for patients 6 years and up after Phase III data in 31 Bardet-Biedl patients showed it decreased BMI by around 8% compared to placebo. Rhythm chairman and CEO David Meeker noted that while BMI was not a perfect measurement, the company opted to use it over weight because its study included pediatric patients who were still growing.
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