Rhythm Pharma: IMCIVREE Gets NICE Recommendation To Treat Obesity, Controlling Hunger

Rhythm Pharmaceuticals, Inc. (RYTM) announced Monday that its IMCIVREE (setmelanotide) has been recommended by the National Institute for Health and Care Excellence or NICE for treating obesity and controlling hunger caused by POMC or LEPR Deficiency in people six years of age and over.

In pre-market activity on Nasdaq, Rhythm Pharma shares were gaining around 5 percent to trade at $10.50.

The commercial-stage biopharmaceutical company focused on hyperphagia and severe obesity caused by rare melanocortin-4 receptor or MC4R pathway diseases said the agency has issued guidance that recommends IMCIVREE as an option for the treatment.

Pro-opiomelanocortin or POMC deficiency, including proprotein convertase subtilisin/kexin type 1 or PCSK1, or leptin receptor or LEPR deficiency are caused by genetic variants that disrupt signaling of the MC4R pathway, a system in the hypothalamus that regulates hunger, satiety and energy expenditure.

Disrupted MC4R signaling causes hyperphagia and early-onset, severe obesity.

With this recommendation under the Highly Specialised Technologies pathway, IMCIVREE will be funded and available for use within 90 days in the National Health Service.

The company noted that the final NICE recommendation is aligned to the approval by European Marketing Authorization or EMA and UK Medicines and Healthcare Products Regulatory Agency or MHRA as the only authorised treatment option for these rare genetic diseases of obesity.

The most common adverse events were skin hyperpigmentation, injection site reactions, nausea and headache.

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