Rhythm Pharmaceuticals (RYTM) said Tuesday that the UK's Medicines & Healthcare products Regulatory Agency has expanded the marketing authorization for Imcivree to include the treatment of obesity and control of hunger associated with Bardet-Biedl syndrome or biallelic pro-opiomelanocortin in patients aged two years and up.
Imcivree initially received marketing authorization for treating obesity and controlling hunger in patients aged six years and older in these indications in 2022, the company said.
With this expanded authorization, the company said Imcivree will be available through the Medicines for Children program by the end of this year.
A supplemental new drug application for Imcivree for patients as young as two years old is currently under priority review with the US Food and Drug Administration, with a decision expected on Dec. 26.
A late-stage clinical trial found that the drug may reduce hyperphagia, weight and body mass index in children, the company said.
免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。