Rhythm Pharmaceuticals Inc. (RYTM), a commercial-stage biopharmaceutical company, announced on Friday that the European Commission had granted a marketing authorization expansion to IMCIVREE in treating acquired hypothalamic obesity.
The European Commission has now authorised an expansion of IMCIVREE (setmelanotide) to include the treatment of obesity and control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment.
The marketing authorization from the European commission (EC) is supported by results from the Phase 3 TRANSCEND trial testing IMCIVREE in treating HO, which achieved the primary endpoint of a 19.8% placebo-adjusted reduction in body-mass index (BMI).
Acquired hypothalamic obesity (HO) is a rare neuroendocrine disorder, caused by hypothalamic injury or impairment, and characterised by accelerated and sustained weight gain. It is estimated that more than 10,000 people in the U.S. are living with the disease, with a similar population of approximately 10,000 individuals affected by acquired hypothalamic obesity in Europe.
The drug is already approved in the European Union (EU) for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above.
The company plans to seek a country-by-country approval in Europe for IMCIVREE in treating HO, with commercial launches expected by 2027.
RYTM closed Friday at $81.81, up 0.55%.
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