GSK's albiglutide won EU approval in 2014 and was withdrawn in 2018

Albiglutide, sold in the European Union as Eperzan, was authorized there for the treatment of type 2 diabetes on March 21, 2014 ^[1]. The European Commission withdrew that marketing authorization on October 29, 2018 ^[1].

The withdrawal was requested by the marketing authorization holder, GlaxoSmithKline Trading Services Limited, which notified the European Commission of its decision to permanently discontinue marketing the product for commercial reasons ^[1]. The European Medicines Agency's public assessment report for Eperzan was updated to show that the authorization is no longer valid, and the medicine's page was last updated on February 20, 2019 ^[1]. The most recent procedure listed as affecting the product information is dated September 14, 2017 ^[1].

Albiglutide is a GLP-1 receptor agonist. Drugs in this class increase insulin secretion and decrease glucagon to control glucose levels, and they also transiently slow gastric emptying, reduce appetite and support weight loss ^[2]. A 2020 review of switching between GLP-1 receptor agonists, published in the journal Clinical Diabetes, notes that albiglutide "was also approved, but has been withdrawn for commercial reasons" ^[2]. The same review lays out how much the class members differ from one another: dulaglutide, liraglutide and semaglutide are analogs of human GLP-1, while exenatide and lixisenatide are built on a different protein, exendin ^[2]. Dosing in the class ranges from twice daily to once weekly, and a once-daily oral formulation of semaglutide has since been approved in the United States ^[2].

Several details about albiglutide's US history have not been reported: the brand name it was sold under in the United States, its US approval date, and the date US sales ended. Sales figures for the drug also have not been reported. The European notice attributes the withdrawal to commercial reasons and does not describe a safety finding ^[1].

Why it matters for patients

Regulatory approval does not guarantee that a medicine stays on the market. Eperzan cleared European regulators and then was withdrawn roughly four and a half years later because its owner decided to stop selling it ^[1].

For patients, an exit of this kind can mean a prescription has to be replaced, a different injection device or schedule has to be learned, and blood sugar may need to be watched while the change settles. That is not a rare event in this drug class. Pharmacy data cited in the switching review suggest up to one-fourth of patients move from their first GLP-1 receptor agonist to another glucose-lowering medicine within the first year of treatment ^[2]. Some patients switch to a different GLP-1 receptor agonist, according to the review, which was written in part because practical guidance on managing those transitions is scarce ^[2].

The reason European regulators give for albiglutide's removal is commercial, and the notice does not describe a safety action ^[1]. For anyone following the GLP-1 class today, the albiglutide case shows that the list of available products changes for business reasons as well as medical ones, and that the options within the class are not interchangeable in how they are taken ^[2].