Albiglutide

Albiglutide (Tanzeum) is a real, FDA-approved once-weekly GLP-1 agonist, approved in 2014 and discontinued by GSK in 2017 for commercial reasons — with a genuinely ironic twist: its positive cardiovascular-outcomes trial was published more than a year after the drug had already been pulled from the market.

The approval

The FDA approved albiglutide (as Tanzeum) on 15 April 2014, a once-weekly GLP-1 receptor agonist for type 2 diabetes, based on the Phase III HARMONY program (8 trials, more than 5,000 patients). Marketed in Europe as Eperzan.

Discontinued for business reasons, not safety

GSK announced on 26 July 2017 that it would discontinue manufacturing and sale of Tanzeum, citing limited prescribing and increasing competition — notably from liraglutide and the imminent launch of semaglutide — rather than any safety concern. US supply was expected to run out by July 2018; the EU withdrawal followed in October 2018. The main tolerability issues in trials were GI side effects (diarrhea, nausea) and injection-site reactions (11-18% of patients), plus the standard GLP-1-class thyroid C-cell boxed warning and a low (0.3% vs. 0% placebo) pancreatitis signal — nothing that reads as a safety-driven withdrawal.

The posthumous positive trial

Here's the genuinely unusual part: GSK had already committed to the HARMONY Outcomes cardiovascular trial and saw it through to completion even after pulling the drug from commercial sale. Published in October 2018 (Lancet, PMID 30291013): 9,463 patients with type 2 diabetes and established cardiovascular disease, median follow-up 1.6 years. The primary composite outcome (cardiovascular death, MI, or stroke) occurred in 7% of the albiglutide group versus 9% on placebo (HR 0.78, 95% CI 0.68-0.90) — a 22% relative risk reduction, and a real, positive, superior result (p=0.0006 for superiority) — arriving in medical journals more than a year after the drug had already left pharmacy shelves.

Why this case study matters

Albiglutide is a useful counterpoint to peginesatide elsewhere on this site: both are discontinued peptide drugs, but for opposite reasons. Peginesatide was pulled because real-world use revealed it was dangerous. Albiglutide was pulled because it wasn't commercially competitive — and then went on to prove, in a trial GSK didn't have to finish, that it actually worked. A drug leaving the market tells you something happened, but not, by itself, what kind of something.