Imcivree now approved in Canada to treat another rare obesity condition
Injection therapy OK'd to help manage weight in children, adults with aHO
Written by |
Imcivree has been approved in Canada to help manage weight in adults and children with acquired hypothalamic obesity. (Image from iStock)
Health Canada has approved Imcivree (setmelanotide) to help manage weight in adults and children in the country who are living with acquired hypothalamic obesity (aHO).
The injection therapy was previously approved in Canada for weight management in people with certain types of genetic obesity, including Bardet-Biedl syndrome and those caused by mutations in POMC, PCSK1, or LEPR genes. Now, Imcivree is also cleared for use in people ages 4 and older with aHO, a form of obesity that can develop after damage to a brain area called the hypothalamus.
“The approval of this additional indication for Imcivree provides healthcare professionals with an important new treatment option for eligible patients in Canada,” Jennifer Lee, executive vice president and head of North America of Rhythm Pharmaceuticals, the therapy’s developer, said in a company press release. “We are grateful to the Canadian patient and healthcare community and look forward to working to make Imcivree available to patients living with acquired hypothalamic obesity.”
Imcivree is also approved for similar indications, including aHO, in the U.S., the European Union, and Japan. In the U.S. and the EU, the drug can be used for treating obesity and controlling hunger in people with aHO, also among those ages 4 and older.
aHO is caused by damage to the hypothalamus — the brain region that keeps the body in balance, including triggering hunger and thirst — that disrupts the normal regulation of hunger and energy. Symptoms of the condition include persistent hunger and burning scant calories at rest, which contribute to rapid and continued weight gain.
Imcivree reduced BMI by nearly 20% in aHO patients in trial
Imcivree is designed to reactivate the melanocortin 4 receptor (MC4R) pathway, which helps regulate feelings of fullness after eating and the body’s energy use. By restoring this signaling, the treatment, given as an injection under the skin, is expected to help reduce excessive hunger and support weight loss, thereby aiding in weight management.
The therapy’s approvals for aHO were based on data from the Phase 3 TRANSCEND clinical trial (NCT05774756), which evaluated Imcivree’s safety and effectiveness in more than 100 aHO patients, 4 years and older. The participants were randomly assigned to receive either Imcivree or a placebo daily for one year.
The trial results, recently published, showed that the treatment was generally safe and significantly reduced — by nearly 20% — participants’ body mass index (BMI) compared with the placebo. BMI is a ratio of weight to height commonly used as a proxy for body fat.
Patients living with acquired hypothalamic obesity face significant medical and quality-of-life challenges, and treatment options have been extremely limited. … This approval provides a treatment option that addresses the underlying … dysfunction associated with [aHO].
Imcivree-treated patients were also significantly more likely to experience a clinically meaningful BMI reduction of 5% or more (83% vs. 21%) and showed a significantly greater reduction in average hunger scores (2.73 vs. 1.45).
“Patients living with acquired hypothalamic obesity face significant medical and quality-of-life challenges, and treatment options have been extremely limited,” said Jill Hamilton, MD, a pediatric endocrinologist at The Hospital for Sick Children in Toronto. “This approval provides a treatment option that addresses the underlying MC4R pathway dysfunction associated with acquired hypothalamic obesity.”
A recent real-world study in France also demonstrated that Imcivree was associated with reduced hunger and improvements in weight-related measures among children with aHO.
Rhythm is now developing other treatments for aHO that target the same pathway as Imcivree: RM-718, a next-generation injectable treatment being developed for once-weekly dosing, and bivamelagon, an oral daily treatment.
Preliminary findings from an ongoing Phase 1/2 trial (NCT06239116) showed BMI reductions in aHO patients treated with RM-718 that were consistent with those seen with Imcivree. Reductions in BMI and hunger were also seen in bivamelagon-treated aHO patients within the Phase 2 SIGNAL trial (NCT06046443).
The company plans to launch a Phase 3 trial evaluating bivamelagon in people with aHO by the end of the year. Should results be positive, they may be used to support regulatory requests seeking the therapy’s approval, according to the developer.
