GSK announces US approval of its once-weekly GLP-1 agonist Tanzeum (albiglutide) – April 15, 2014

The US FDA has approved GSK’s once-weekly GLP-1 agonist albiglutide (US brand name: Tanzeum) just in time (on the dot!) for the candidate’s April 15 PDUFA date; a US launch is planned for 3Q14. Surprisingly, in addition to the requisite press release, the company also held a media call on the news. As background, Eperzan (albiglutide’s brand name in the EU) was approved in Europe late last month, and European launches are planned starting in 3Q14 and extending into 4Q14 and beyond (read our report for much more detail on albiglutide). Overall, it was great to hear news of Tanzeum’s approval; presumably, the FDA felt confident enough that it did not convene an advisory committee meeting so although this was pretty much expected, as we got closer to Tax Day with no news, we wondered if there would be some unexpected news. Notably, the drug has a relatively favorable side effect profile relative to other GLP-1 agonists (especially with regards to nausea); and the drug’s glucose-lowering efficacy appeared solid in phase 3, although albiglutide just missed non-inferiority against Novo Nordisk’s once-daily Victoza (liraglutide) in Harmony 7 (albeit with a narrow 0.2% non-inferiority margin).

GSK organized a brief (~20 minute) media call on the news in the afternoon – listener questions ranged from the thyroid warning on the label (consistent across GLP-1 agonists), to the relevance of the product for primary care physicians, to the once-weekly GLP-1 agonist competitive landscape. During the call, endocrinologist and GSK Medical Affairs Lead Dr. Molly Carr highlighted the major differentiating factors for Tanzeum over AZ’s once-weekly Bydureon (currently the only other once-weekly GLP-1 agonist on the market): (i) five of GSK’s eight phase 3 studies ran for three years, providing excellent long-term safety and efficacy data; and (ii) Tanzeum has a “great tolerability profile,” with nausea and vomiting rates nearly on par with placebo, three-fold lower than was seen with Victoza in a head-to-head study. That is particularly favorable from our view, as it should be associated with a better rap with HCPs who don’t like (and don’t have time for an aren’t reimbursed for) extra phone calls from patients. Other advantages of Tanzeum that are class-wide include low rates of hypoglycemia and moderate weight loss. Tanzeum’s injection device seems to be on par with the Bydureon dual-chambered pen in terms of ease of use but we’ll be very eager to try it and to watch how patients like and use it – this can make a major difference in patient and HCP preferences although of course, most important of all is reimbursement questions, early formulary status, etc. We did not receive much detail here, but Dr. Carr mentioned a “three-click” process that includes a 15-minute “reconstitution time” – the 15 minutes may well be perceived as adding hassle, and there’s some of that associated with so many GLP-1 products (see our report on the recent approval of Bydureon’s dual-chambered pen).

• The FDA has mandated the following three post-marketing studies for Tanzeum, including a cardiovascular outcomes trial (CVOT). A meta-analysis of phase 2/3 data on Tanzeum met the FDA’s pre-specified threshold, and therefore the drug did not require pre-approval CVOT data. Additionally, the FDA is requiring a trial to evaluate efficacy and safety in pediatric patients, as well as a medullary thyroid carcinoma registry of at least 15 years duration. We do not imagine that this registry will pick up any major worrying signals, as no increase in thyroid C-cell tumors has been picked up in extensive clinical study of the GLP-1 agonist class.

-- by Manu Venkat, Jessica Dong, and Kelly Close