Is Mecasermin legal in the United Kingdom?

An approved medicine, and only for a rare paediatric deficiency. In 76 children with severe IGF-1 deficiency, height velocity rose from 2.8 cm per year at baseline to 8.0 cm per year in the first year, and 49 percent had hypoglycaemia. Among registry patients followed to the end of puberty, mean height moved from about 3.7 to about 2.6 standard deviations below the mean in boys: better, still short.

Mecasermin is recombinant human IGF-1, the mature 70 amino acid hormone, given by subcutaneous injection twice daily with food. It is the only entry in this batch that is an approved medicine, and it is approved for one narrow thing: growth failure in children and adolescents with severe primary IGF-1 deficiency, and in children with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.

Mechanism: Mecasermin binds the IGF-1 receptor, a receptor tyrosine kinase, activating PI3K/Akt and MAPK signalling to drive cell growth, protein synthesis and, at the growth plate, linear bone growth. It also has meaningful affinity for the insulin receptor, which is the direct reason hypoglycaemia is the principal adverse effect and why the product is dosed with a meal.

Regulatory history: FDA-approved. INCRELEX (mecasermin), BLA 021839, sponsor Ipsen, original approval 30 August 2005, prescription only. Indicated for growth failure in children with severe primary IGF-1 deficiency and in children with growth hormone gene deletion who have developed neutralising antibodies to growth hormone. It is not approved for adults, for sarcopenia, for recovery or for any performance use.

Licenses medicines for the UK market. A compound without a marketing authorisation is an unlicensed medicine, which can only lawfully be supplied for human use through a prescriber under the specials scheme, not sold as a research product.

The classification above is the The Longevity Archive reading of Medicines and Healthcare products Regulatory Agency listings for Mecasermin at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.