Is Albiglutide legal in Australia?

A once-weekly GLP-1 receptor agonist approved in 2014 and withdrawn from every market by 2018.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 EU authorisation (Eperzan) granted March 2014 and withdrawn 29 October 2018 at the holder's request.

Registers or lists therapeutic goods on the ARTG and schedules substances in the Poisons Standard. Many peptides are Schedule 4 (prescription only), so possession without a prescription and personal importation are restricted even when no product is registered.

The classification above is the The Longevity Archive reading of Therapeutic Goods Administration 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.