Thursday was a busy day for Europe’s regulators—and one that’ll send several drugmakers into the weekend happy.
The Committee for Medicinal Products for Human Use (CHMP) recommended six medications for European Medicines Agency (EMA) approval. The gatekeeper panel also gave its thumbs-up to new indications for three existing drugs. And some of those products just happen to be competing in ultrahot fields where new nods could shake things up. We’ve rounded up the highlights below.
- The CHMP looked favorably on Juluca, the HIV newcomer from GlaxoSmithKline and Johnson & Johnson's Janssen. The combo med is the result of a gamble by the British drugmaker, which became the first to market a two-drug HIV cocktail—as opposed to three drugs or more—when it won its FDA green light in November. Still, Gilead has some stiff new competition of its own in Biktarvy, which contains three drugs but is expected to rake in billions nonetheless.
- PARP inhibitors make up one of the hottest fields in oncology right now, and among that group, Clovis Oncology's Rubraca picked up a CHMP recommendation to treat relapsed or progressive ovarian cancer. The Clovis medication is locked in a battle with AstraZeneca’s Lynparza and Tesaro’s Zejula, and it’s working to join its rivals in the ovarian cancer maintenance setting.
- Novartis’ Sandoz, which pioneered biosimilars in the U.S., is at it again. This time it’s with a copy of blockbuster Remicade—dubbed Zessly—which CHMP endorsed this week. Sandoz won’t be the first to go after that immunology giant, which Merck markets overseas; by late last year, Remicade’s European market share had fallen by 50% thanks to other biosim players. In the U.S., it's a different story; Remicade's stateside rep Johnson & Johnson has so far successfully held off Pfizer’s Inflectra.
- Elsewhere in the biosim sphere, Amgen picked up backing for Kanjinti, its version of Roche cancer standout Herceptin. While generics giant Mylan boasts an FDA approval for its own Herceptin biosim, it faced a slowdown in the EU last year when it withdrew its marketing application. Mylan resubmitted in December, meaning competition for Kanjinti is on the horizon if the U.S.-based generics specialist can snag the EMA’s go-ahead.
- Amgen’s second CHMP victory of the week was for Repatha, the PCSK9 cholesterol fighter that’s locked in a head-to-head rivalry with Sanofi and Regeneron’s Praluent. CHMP moved to update Repatha’s label based on data from Amgen’s Fourier outcomes study, which showed that the drug could cut cardiovascular risk in patients with established atherosclerotic cardiovascular disease by lowering LDL-C levels.