J&J's Vokanamet (canagliflozin-metformin IR) receives positive CHMP opinion – February 25, 2014

The European Committee for Medicinal Products for Human Use (CHMP) announced last week that it has adopted a positive opinion on J&J's Vokanamet, a fixed-dose combination (FDC) of its SGLT-2 inhibitor Invokana (canagliflozin) and metformin IR. The combination will be available for three primary indications: (i) patients not adequately controlled on maximally tolerated doses of metformin; (ii) patients on maximal doses of metformin along with other glucose-lowering drugs (including insulin); and (iii) patients already being treated with the combination of canagliflozin and metformin as separate tablets. Vokanamet will be available in four dose combinations (canagliflozin 50 mg or 150 mg, metformin IR 850 mg or 1,000 mg) and will be dosed twice daily. FDCs represent an exciting way to simultaneously improve patient adherence, cut patient costs, and (from a manufacturer's perspective) differentiate products in an increasingly crowded diabetes competitive landscape (see our AZ 4Q13 Report for AZ CEO Pascal Soriot's thoughts on using FDCs as a way to defend against pricing pressure in Europe). The four dosing choices may be a bit complicated for some HCPs, giving time constraints; on the other hand, having different titration choices is important. As a reminder, AZ's SGLT-2/metformin FDC Xigduo received marketing authorization in Europe less than a month ago (see item #3 of our January 28, 2014 Letter), making it the first FDC of its class approved in the US or EU. Assuming the EMA grants Vokanamet marketing approval in the next month or two, it will be only slightly behind Xigduo. Vokanamet received a complete response letter (CRL) from the US FDA in December (see item #3 of our December 17, 2013 Letter) asking for more information on whether the twice-daily dosing regimen is comparable to the once-daily dosing of the approved canagliflozin single agent (relatively easy, as CRLs go). J&J is also developing a FDC of canagliflozin/metformin XR, which is currently in phase 3 testing in the US.