Anti obesity drug approved in UK to ease hunger, promote weight loss
Developer plans to work with NHS to get therapy to aHO patients 4 and older
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Imcivree is an anti obesity drug designed to curb hunger and help patients lose weight. (Image by iStock)
Imcivree (setmelanotide), Rhythm Pharmaceuticals’ anti obesity drug, is now approved in the United Kingdom to help promote weight loss and control hunger in people as young as age 4 with acquired hypothalamic obesity (aHO).
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the drug’s marketing authorization to include aHO, Rhythm announced in a company press release. That decision adds the rare disorder, which can develop after damage to a brain area called the hypothalamus, to the list of approved uses of Imcivree in the U.K.
“Patients with acquired HO often experience persistent hunger and rapid, severe weight gain that can affect nearly every aspect of their daily life,” said David Meeker, MD, chairman, president and CEO of Rhythm.
According to Meeker, this approval “marks an important milestone for patients in the UK living with acquired HO.”
The therapy had already been cleared by the MHRA to manage obesity and control hunger in people with certain genetic conditions affecting hunger regulation in the brain. That includes Bardet-Biedl syndrome, an inherited multisystemic disorder that can also lead to obesity.
Rhythm said it would be working closely with the U.K.’s National Health Service (NHS) to finalize plans for coverage of Imcivree in people with aHO.
“With the MHRA’s expanded authorization of IMCIVREE, healthcare providers now have an approved treatment option for eligible patients that addresses the underlying biology of [aHO],” Meeker said.
The decision in the U.K. follows similar expansion approvals of Imcivree to treat aHO in the U.S. and the European Union.
Rhythm granted 10 years’ market exclusivity for Imcivree
In addition, the therapy was awarded orphan drug status by the MHRA for aHO, according to Rhythm. That designation provides reductions on marketing authorization fees and a market exclusivity of 10 years in Great Britain.
aHO is marked by damage to a part of the brain called the hypothalamus, which serves much like a master switch for keeping the body balanced. Normally, this brain region can activate the melanocortin 4 receptor (MC4R) signaling pathway, which is helps regulate appetite. Imcivree, administered via a once-daily injection, is designed to activate this pathway, thereby restoring normal signaling to regulate hunger.
“Acquired hypothalamic obesity is a complex condition that can have profound effects on the quality of life and long-term health of children and adults with brain tumors affecting the hypothalamus,” said Sadaf Farooqi, MD, PhD, of the University of Cambridge in the U.K.
The TRANSCEND study showed substantial reductions in BMI in adults and children, demonstrating the effectiveness of [this] pathway-targeted therapy in people with [aHO].
The MHRA’s approval of Imcivree for aHO was based largely on data from the global Phase 3 TRANSCEND clinical trial (NCT05774756), which tested Imcivree against a placebo in more than 100 people with aHO. The goal was to evaluate the therapy’s effect on body mass index (BMI), which is a ratio of weight to height commonly used as a proxy of body fat.
After one year, average BMI decreased by 17% with Imcivree and increased by 3% with the placebo, meeting the trial’s main goal. Also, more than three-quarters of participants given Imcivree experienced a BMI reduction of 5% or more compared with less than one-quarter of those on the placebo (83% vs. 21%).
Data from TRANSCEND also indicated that Imcivree helped reduce patient-reported hunger. The most commonly reported adverse events with the therapy were nausea, vomiting, diarrhea, injection site reaction, skin darkening, and headache.
“The TRANSCEND study showed substantial reductions in BMI in adults and children, demonstrating the effectiveness of MC4R pathway-targeted therapy in people with this condition,” Farooqi said. “These results provide strong evidence for a targeted treatment approach in a condition for which there were previously no approved therapies in the UK.”
