- The FDA has extended the review period for Rhythm Pharmaceuticals Inc's (NASDAQ:RYTM) supplemental marketing application for Imcivree (setmelanotide) for obesity and control of hunger with Bardet-Biedl Syndrome (BBS) or Alström syndrome.
- The Prescription Drug User Fee Act (PDUFA) goal date has been revised to June 16, 2022, from March 16.
- FDA requested additional subgroup analyses of the clinical efficacy data from Rhythm's Phase 3 pivotal trial in BBS and Alström syndrome.
- No new data were requested. The additional information has been deemed a 'major amendment' to the sNDA, which requires extra time to review.
- Related: Rhythm Pharma's Highlights Interim Setmelanotide Data In Long Term Genetic Disorder Trial.
- The major amendment did not include any information relating to the safety or manufacturing of setmelanotide.
- Rhythm also withdrew Alström syndrome indication from its pending Type II variation application to the European Medicines Agency for setmelanotide for obesity and control of hunger in adult & pediatric patients six years of age and older with BBS.
- The Company continues to evaluate the next steps relative to seeking marketing authorization for use in patients with Alström syndrome in the European Union.
- Price Action: RYTM shares are down 13.30% at $7.26 during the market session on the last check Thursday.
