Rhythm Completes Submission of SNDA for Imcivree in Bardet-Biedl and Alstrom Syndromes
September 20 2021 - 8:48AM
Dow Jones News
By Michael Dabaie
Rhythm Pharmaceuticals Inc. said it completed its supplemental
new drug application to the U.S. Food and Drug Administration for
Imcivree for the treatment of obesity and control of hunger in
adult and pediatric patients with Bardet-Biedl syndrome or Alstrom
syndrome.
BBS and Alstrom syndrome are ultra-rare genetic diseases that
affect multiple organ systems. Insatiable hunger and severe obesity
beginning early in life may be common in people living with either
BBS or Alstrom syndrome.
The FDA typically has a 60-day filing review period to determine
whether the supplemental new drug application is sufficiently
complete and acceptable for filing. Rhythm requested priority
review for the application.
Rhythm said in December its Phase 3 trial of setmelanotide in
patients with BBS or Alstrom syndrome met its primary objective and
all key secondary endpoints, with statistically significant and
clinically meaningful reductions in weight and hunger at 52 weeks
on therapy. All primary endpoint responders were patients with BBS,
and no patients with Alstrom syndrome met the primary endpoint of
more than 10% weight loss, the company said.
"While there are limited data for the ultra-rare Alstrom
syndrome population, there is clear evidence of a marked and
sustained weight loss in older children and adults, and consistent
reductions in BMI-Z score in younger patients," Rhythm Chairman and
Chief Executive David Meeker said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
September 20, 2021 08:33 ET (12:33 GMT)
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