FDA extends review period for Imcrivree to treat patients with Bardet-Biedl syndrome or Alström syndrome.- Rhythm Pharmaceuticals
Rhythm Pharmaceuticals, Inc. announced that the FDA has extended by three months the review period for the supplemental New Drug Application (sNDA) for Imcrivee (setmelanotide) for the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with Bardet-Biedl Syndrome (BBS) or Alström syndrome.
The FDA has notified the Company that the Prescription Drug User Fee Act (PDUFA) goal date has been revised to June 16, 2022. The FDA this month 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 additional time to review. The major amendment did not include any information relating to the safety or manufacturing of setmelanotide.
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