A new medication called setmelanotide has been approved in the US by the FDA (Food and Drug Administration) for childhood obesity. FDA is an organisation of the department of health and human services which works to protect the public health by ensuring safety, efficacy and security of all human and veterinary medications.
Setmelanotide and its trade name Imcivree, has now been approved for weight loss and weight maintenance in children aged six years and older with obesity resulting from three rare genetic conditions. These genetic conditions include:
- POMC (Pro-opiomelanocortin) deficiency
- Proprotein subtilisin/kexin type 1 (PCSK1) deficiency
- Leptin receptor (LEPR) deficiency
The genetic deficiencies above play a key role in affecting the hormones and chemicals involved in eating behaviour and metabolism.
This medication, setmelanotide should only be given to children with obesity who have had confirmed genetic tests, which are positive for any variants in POMC, PCSK1, or LEPR genes and are considered to be the cause for weight gain. setmelanotide should not be given if there is only a suspicion of POMC, PCSK1, or LEPR deficiency or any other genetic syndromes. The commonest form of genetic problem leading to obesity is MC4R gene mutation. Setmelanotide is however, not currently approved for MC4R.
One should be aware that setmelanotide leads to weight loss by altering the eating behaviour. It changes the hunger and fullness but does not treat or cure the underlying genetic problem.
The two studies conducted with the medication setmelanotide for childhood obesity were for a duration of one year and the participants lost more than 10% of their body weight after one year. In total there were around 20 participants. Long term studies and post marketing evaluation is required to understand the long-term benefits of this medication.
During the study, the most common side effects experienced by children on setmelanotide included injection site reactions, skin hyperpigmentation, headache, and gastrointestinal side effects, among others. Other rare side effects were also reported.
You can read more on the FDA website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-first-treatment-weight-management-people-certain-rare-genetic-conditions
and also in the Lancet (Diabetes & Endocrinology):
https://www.thelancet.com/journals/landia/article/PIIS2213-8587(20)30364-8/fulltext
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Author: Dr C.Rajeswaran
Dr C. Rajeswaran is a diabetes consultant. As a private diabetes consultant he has private diabetes clinics in Harley Street, London, Claremont Hospital, Sheffield, Nuffield Hospital, Leeds and simplyweight, Bradford.
He has face to face consultations with people with thyroid problems from Leeds, Sheffield, Barnsley, York, Rotherham, Chesterfield, Doncaster, Wakefield, Huddersfield, Bradford, Harrogate, Leeds, Hull, Sheffield and London. He also offers video consultations.
