Adolescent Obesity Medication Prescriptions Surge 301% Despite Persistent Access Barriers
Obesity medication prescriptions among US adolescents aged 12-17 years increased by 301.7% between 2020 and 2023, driven primarily by FDA approvals of semaglutide and phentermine-topiramate for pediatric use.
Rhythm Pharmaceuticals' Imcivree Shows Significant Weight Loss in Phase III Hypothalamic Obesity Trial
Rhythm Pharmaceuticals' Imcivree (setmelanotide) demonstrated a 19.8% placebo-adjusted reduction in BMI over 52 weeks in patients with acquired hypothalamic obesity, a rare condition caused by hypothalamic damage.
Rhythm's Imcivree Shows Significant Weight Loss in Patients with Hypothalamic Obesity
Rhythm Pharmaceuticals' setmelanotide (Imcivree) demonstrated a 16.5% reduction in body weight compared to a 3.3% gain with placebo in patients with hypothalamic obesity over 52 weeks of treatment.
Rhythm Pharmaceuticals Regains Global Control of IMCIVREE by Reacquiring Rights in China
Rhythm Pharmaceuticals has terminated its 2021 licensing agreement with RareStone Group Ltd., reacquiring rights to IMCIVREE (setmelanotide) in mainland China, Hong Kong, and Macau for $6.3 million.
Setmelanotide Receives Orphan Drug Designation in Japan for Hypothalamic Obesity Treatment
Rhythm Pharmaceuticals' setmelanotide has received orphan drug designation from Japan's Ministry of Health for the treatment of acquired hypothalamic obesity, a rare condition affecting an estimated 5,000-8,000 patients in Japan.
Rhythm Pharmaceuticals Announces Positive IMCIVREE® Sales and Pipeline Advancements
Rhythm Pharmaceuticals reports preliminary unaudited net revenues of approximately $42 million for Q4 2024 and $130 million for full year 2024 from global IMCIVREE® sales.
Novo Nordisk's Cagrilintide/Semaglutide Combo Shows Superior Weight Loss in Phase III Trial
A fixed-dose combination of cagrilintide and semaglutide led to greater weight loss at 68 weeks compared to either drug alone or placebo in the REDEFINE 1 trial.
FDA Expands Setmelanotide Approval to Include Children Aged 2-5 with Rare Obesity Forms
The FDA has expanded the approval of setmelanotide (Imcivree) to include children aged 2 to 5 years with rare genetic forms of obesity.
FDA Gears Up for Year-End Decisions on Novel Therapies for Rare Diseases and Cancer
• The FDA is set to decide on Ionis Pharmaceuticals' olezarsen for familial chylomicronemia syndrome (FCS), a rare genetic disease, by December 19, following positive Phase III results. • Lexicon Pharmaceuticals awaits the FDA's decision on sotagliflozin as an adjunct therapy for type 1 diabetes by December 20, despite concerns raised by an advisory committee. • AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC is under FDA review, with a decision expected by December 20, based on Phase III data showing progression-free survival benefits. • Neurocrine Biosciences anticipates FDA decisions on crinecerfont for congenital adrenal hyperplasia (CAH) by December 29 and 30, potentially marking the first new treatment in 70 years.
Setmelanotide Shows Promise in Reducing Obesity in Young Children with Rare Genetic Deficiencies
A Phase 3 trial of setmelanotide in children aged 2-5 with BBS, POMC, PCSK1, or LEPR deficiency demonstrated clinically meaningful reductions in BMI Z-score.