The latest set of opinions from advisors to the European Medicines Agency include recommendations to approve six new medicines, including Bristol-Myers Squibb’s new hepatitis C drug and Eli Lilly’s biosimilar of the Sanofi diabetes blockbuster Lantus.  

First up, the agency's Committee for Medicinal Products for Human Use has backed granting marketing authorisation for B-MS’ Daklinza (daclatasvir) in combination with other drugs for the treatment of chronic HCV. It is the first of a new class of antivirals that block the action of NS5A, a protein which is essential for HCV to replicate, and will form the basis of a three-drug all-oral combination the company is developing, along with asunaprevir and BMS-791325, which itself

Daklinza is also being studied in combination with Gilead Sciences’ HCV game-changer Sovaldi (sofosbuvir) in high unmet need patients. Elliott Levy, head of specialty development at B-MS, noted that through its early access programmes in Europe, more than 2,000 HCV patients with advanced liver disease have already been treated with the Daklinza/Sovaldi combo.

The CHMP also recommended expansion of B-MS and Pfizer’s bloodthinner Eliquis (apixaban) for deep vein thrombosis and pulmonary embolism, and the prevention of recurrent forms of both conditions. It is already approved for stroke prevention in atrial fibrillation patients and to reduce the risk of blood clots following hip or knee replacements.

The committee also gave its backing to Lilly’s copy of Lantus, Abasria (insulin glargine) the first approved biosimilar insulin. Studies have shown Abasria to have a comparable quality, safety and efficacy profile to Lantus, the CHMP said, while also insisting on a pharmacovigilance plan being implemented as part of the marketing authorisation.

There were also positive opinions for ViiV Healthcare’s HIV treatment Triumeq (abacavir/dolutegravir/lamivudine) and Vifor Fresenius Medical Care Renal Pharma's hyperphosphatemia drug Velphoro (sucroferric oxyhydroxide). The CHMP also backed GE Healthcare’s Vizamyl (flutemetamol [18F])) to detect amyloid-beta neuritic plaques in the brain of patients with cognitive impairment suspected of having Alzheimer's disease and Teva’s clopidogrel/aspirin combo for the prevention of atherothrombotic events.

Among the other highlights from the CHMP meeting, the panel recommended extensions of indications for Pfizer’s Enbrel (etanercept), Bayer’s Eylea (aflibercept) and Stivarga (regorafenib), Merck Sharp and Dohme’s Isentress (raltegravir) and  Vertex’ Kalydeco (ivacaftor).