As increasing varieties of drugs aimed at weight loss hit the shelves, a new treatment that targets obesity and hunger control with a genetic cause will soon be available on England and Wales’ NHS.
This news comes after the National Institute for Health and Care Excellence (NICE) recommended Rhythm Pharmaceuticals’ Imcivree (setmelanotide) injection for the treatment of obesity and extreme hunger – also known as hyperphagia – in patients with Bardet-Biedl syndrome.
Those who are genetically confirmed to have the disease and between six and 17 years of age will be eligible to start the therapy. Patients who continue to benefit from treatment can carry on taking the injection into adulthood.
US-based Rhythm expects Imcivree will be funded and available on the NHS in England and Wales within the next three months.
The biotech stated it is also pressing ahead with a submission to the Scottish Medicines Consortium, with a decision expected next year.
Bardet-Biedl syndrome is a rare genetic condition that affects many parts of the body. In addition to issues with vision, the number of digits, and kidney function, all of which are impaired in this condition, early obesity is a major clinical feature of the disease. According to the NHS, Bardet-Biedl syndrome patients struggle to manage their weight due to lower energy needs and hyperphagia.
UCL Great Ormond Street Institute of Child Health’s Dr Philip Beales said: “Hyperphagia – the feeling of extreme hunger that stays with patients all the time – leads to early-onset, life-long, severe obesity that affects many aspects of daily living. Until now there have been no licensed treatments for obesity and hyperphagia caused by [Bardet-Biedl syndrome].”
Rhythm’s Imcivree can reduce weight and body mass index (BMI), along with lowering hyperphagia. The injection works by activating melanocortin receptor 4, which promotes a feeling of fullness after eating.
The drug was approved in Europe for treating obesity and the control of hunger associated with deficiency of three genes in 2021. The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) expanded approval in 2022 to include patients with Bardet-Biedl syndrome.
Rhythm has plans for the drug beyond the currently approved indications. The biotech reported positive results from a Phase II trial investigating Imcivree in the treatment of hypothalamic obesity last year.
In January 2024, the company added a clinical-stage weight loss drug to its portfolio after licensing South Korea-based LG Chem’s LB54640 in a deal worth up to a potential $305m.
