The US Food and Drug Administration (FDA) expanded the use of Rhythm Pharmaceuticals’ therapy for a rare form of obesity caused by brain damage, making it the first treatment to be approved in the US for the condition.
Shares of the company were up 6.6% at $96.34 pre-market.
The therapy received approval on Thursday to treat acquired hypothalamic obesity, which causes excess and sustained weight gain due to injuries such as tumour growth or stroke in the brain.
The hypothalamus of the brain regulates appetite and affects how the body burns calories and stores fat. Rhythm estimates there are 10,000 people living with this condition in the US.
The therapy, chemically known as setmelanotide, is already approved under the brand name Imcivree to treat genetic obesity in adults and children aged two years and older.
We now have hope that there is something out there that could work for this condition, and also that it will hopefully open doors to other potential treatments in the future
— Amy Wood, Raymond A Wood Foundation executive director
Imcivree for hypothalamic obesity will be available for patients in the US immediately, the company said. It is administered as a once-daily injection and is designed to activate the MC4R pathway in the brain to reduce hunger and help the body burn more energy.
The approval is backed by a late-stage study in which setmelanotide reduced weight by 15.8% as measured on the body mass index (BMI) at 52 weeks, compared with a 2.6% increase for patients on placebo.
Amy Wood, executive director of patient advocacy group Raymond A Wood Foundation, said the families of those suffering from hypothalamic obesity go through a lot of “failed experiments” as there are currently no approved treatments.
“We now have hope that there is something out there that could work for this condition, and also that it will hopefully open doors to other potential treatments in the future,” said Wood.
Citizens Bank analyst Jonathan Wolleben estimates 2026 Imcivree sales to be $290m, including $34m for hypothalamic obesity.
Reuters
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