Roche, Boehringer and Gilead line up for EU drug approvals

The European Medicines Agency is moving toward approving a trio of novel medicines from Roche ($RHHBY), Boehringer Ingelheim and Gilead Sciences ($GILD), handing down positive recommendations for each.

The EMA's Committee for Medicinal Products for Human Use has taken a favorable stance on Roche's Exelixis ($EXEL)-partnered cancer drug cobimetinib, an antidote to the blood-thinning Pradaxa from Boehringer, and Gilead's latest combination HIV treatment. Each recommendation is generally followed by a full approval within three months.

For Roche and Exelixis, cobimetinib's recommendation follows positive Phase III data in which the drug, combined with Zelboraf, helped patients with melanoma live significantly longer without tumor growth than those treated with the old drug alone, hitting the primary goal of progression-free survival. In the U.S., the pair are still awaiting FDA approval after an agency-mandated delay pushed the decision date from Aug. 11 to Nov. 11. Roche and Exelixis plan to market the drug under the brand name Cotellic once it's approved.

Boehringer's Pradaxa antidote, dubbed Praxbind, is in line for a swifter approval thanks to the EU's accelerated assessment program. The new drug is designed to quickly reverse the effects of the anticoagulant Pradaxa to treat bleeding episodes. And in late-stage trials, Praxbind did just that, counteracting its opposite treatment within about 5 minutes. Boehringer submitted the antidote to the FDA in March and expects to pick up U.S. approval this year.

And Gilead, advancing a slew of one-pill HIV combinations, is now a step closer to approval for one called Genvoya. The drug combines emtricitabine, approved as Emtriva; cobicistat, cleared as Tybost; elvitegravir, on the market as Stribild; and the investigational tenofovir alafenamide, which is a souped-up version of the active ingredient in the company's Viread. Together, the agents hinder HIV's ability to replicate itself within the body, attacking the virus' DNA. Gilead submitted the drug for FDA approval in November.

Capping a busy week, the EMA also passed down positive recommendations for Amgen's ($AMGN) leukemia drug Blincyto, Biogen's ($BIIB) hemophilia A treatment Elocta (approved as Eloctate in the U.S.), Novartis' ($NVS) heart failure therapy Entresto and Vertex Pharmaceuticals' ($VRTX) cystic fibrosis combo Orkambi.

- read the cobimetinib release (PDF)
- here's the Praxbind statement (PDF)
- and the Genvoya announcement (PDF)

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