FDA gives Rhythm the green light for set­melan­otide, a drug aimed at re­duc­ing obe­si­ty in cer­tain ge­net­ic dis­or­ders

A lit­tle over a year af­ter com­plet­ing suc­cess­ful piv­otal tri­als, Rhythm Phar­ma­ceu­ti­cals $RYTM has its first drug ap­proval on its hands.

The Boston-based biotech an­nounced Fri­day that the FDA gave set­melan­otide the thumbs-up for three rare ge­net­ic dis­or­ders that re­sult in obe­si­ty in pa­tients six and old­er. It’s the agency’s first such ap­proval, Rhythm said, with the in­di­cat­ed de­fi­cien­cies be­ing the POMC, PC­SK1 and LEPR genes. Rhythm will mar­ket the drug as Im­civree, and plans to have it on the shelves in the first quar­ter of 2021.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.