- GSK announced that the EMA has approved its once-weekly GLP-1 agonist Eperzan (albiglutide); the candidate has a US FDA PDUFA date of April 15, 2014.
- This makes Eperzan the second once-weekly GLP-1 agonist approved anywhere (following AZ’s Bydureon), with a broader EU indication than Bydureon.
Last week, GSK announced that it received positive marketing authorization from the European Medicines Agency (EMA) for its once-weekly GLP-1 agonist Eperzan (albiglutide). Eperzan becomes the second once-weekly GLP-1 agonist approved in Europe (or anywhere, for that matter), following AZ’s Bydureon (exenatide once weekly), which was approved in Europe in June 2011 (read our report). The company press release guides for commercial launches in “several countries in Europe” over the course of 3Q14 and 4Q14, with “additional launches to follow thereafter.” We learned during the company’s 4Q13 and full-year 2013 update that GSK no longer plans to seek a partner for Eperzan’s commercialization, and instead plans to use Eperzan as a springboard for the development of a broader cardiometabolic franchise – it is always exciting to learn of a company that plans to enter (or re-enter) the metabolic disease area in a big way, especially as 2013 was an especially challenging year for diabetes companies (rising reimbursement pressure, high-profile candidate discontinuations, BMS’ departure).
Eperzan’s approved indications are for the treatment of type 2 diabetes as monotherapy, as an add-on to oral antihyperglycemic agents, and as an add-on to basal insulin. Notably, this is a broader indication than the EU indication for Bydureon, which is approved only as an add-on to oral antihyperglycemic medications (metformin, SFUs, and TZDs) – the indication for use with basal insulin is especially valuable, although we would not be surprised to see off-label use of GLP-1s and basal insulin even if it were not in the label. Having it on-label is valuable to assure PCPs about safety and to make reimbursement more likely. During this January’s JP Morgan Healthcare Conference, GSK Chief Financial Officer Mr. Simon Dingemans emphasized that Eperzan should be well-positioned on the GLP-1 agonist market due to the company’s unique head-to-head data versus insulin, which is not a comparison that some other GLP-1 agonist manufacturers have highlighted (presumably due to their simultaneous presence on the insulin market). A key determinant of Eperzan’s performance will likely be the results of the phase 3 Harmony 7 trial, in which Eperzan missed achieving non-inferiority against Novo Nordisk’s once-daily GLP-1 agonist Victoza (liraglutide) – Eperzan achieved a 0.78% A1c reduction as compared to 0.99% with Victoza, with a non-inferiority margin of 0.2% (read our report on the Harmony 7 results for more details). It is also worth pointing out, however, that Eperzan (compared to Victoza in Harmony 7) was associated with significantly less nausea (9.9% versus 29.2%) and vomiting (5.0% versus 9.3%). It will be key to see how prescribers weigh Eperzan’s slight efficacy disadvantage against the tolerability advantage (along with the once-weekly convenience). Eperzan will be available in a pen device, which will contain and simplify the reconstitution process (we imagine it might be roughly similar to the Bydureon dual-chambered pen, which was recently approved by the FDA).
- Eperzan is also under regulatory review in the US, where its FDA PDUFA date is set for April 15 (an extension of the original date); the lack of a FDA Ad Comm, which is quite rare for type 2 diabetes drugs these days, suggests that the agency did not have any major outstanding questions on the drug.
- The drug is the first of a series of once-weekly GLP-1 agonists to potentially reach the market in the relatively near future. Lilly’s dulaglutide was submitted in the US and EU, placing possible regulatory decisions in late 2014. Novo Nordisk’s semaglutide is currently undergoing phase 3 testing. AZ’s dual-chambered pen for once-weekly Bydureon was just approved, and the company is still working on a once-weekly suspension formulation for the product (slated for 2015 submission). The longest-acting candidate in the field is Intarcia’s ITCA-650, an osmotic exenatide mini-pump that would be implanted once or twice a year (see our JP Morgan Report for remarkable phase 3 data presented on that candidate.
-- by Manu Venkat and Kelly Close