Is Albiglutide legal in the United Kingdom?

A once-weekly GLP-1 receptor agonist approved in 2014 and withdrawn from every market by 2018. In the 9,463 person Harmony Outcomes trial it reduced cardiovascular death, heart attack or stroke by 22 percent against placebo, and in a head to head trial it lowered HbA1c less than liraglutide. The drug is no longer available anywhere.

Albiglutide is a recombinant fusion protein: two tandem copies of human GLP-1 (7-36), each with glycine replacing alanine at position 8 to resist DPP-4, fused to human albumin. The albumin gives it a half-life of about 5 days and once-weekly dosing, and a molecular weight of 72,970 daltons, which makes it by far the largest molecule ever sold as a GLP-1 drug.

Mechanism: Albiglutide activates the GLP-1 receptor: glucose-dependent insulin secretion, suppression of glucagon, slower gastric emptying and reduced appetite, the same mechanism as every drug in the class. Two features set it apart.

Regulatory history: FDA approved 15 April 2014 (Tanzeum, BLA 125431) for glycaemic control in adults with type 2 diabetes. Drugs@FDA marketing status: Discontinued. EU authorisation (Eperzan) granted March 2014 and withdrawn 29 October 2018 at the holder's request.

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 Albiglutide 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.