David Meeker, Rhythm Pharmaceuticals CEO and chairman

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.

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.