• The US FDA has approved Imcivree for chronic weight management in adult & pediatric patients aged ≥6yrs. with obesity due to POMC- PCSK1 or LEPR deficiency confirmed via genetic testing
• The approval is based on results of P-III trials that demonstrated 80% of patients with obesity due to POMC or PCSK1 deficiency achieved >10% weight loss & 45.5% of patients with obesity due to LEPR deficiency achieved >10% weight loss after 1yr of treatment
• The US FDA issued a Rare Pediatric Disease PRV to Rhythm with the approval. The PRV can be redeemed to receive PR for any marketing application or sold/ transferred to other companies for their programs. The therapy is under EMA’s review for approval

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