CHMP approves six drugs including daclatasvir
pharmafile | June 30, 2014 | News story | Sales and Marketing | BMS, CHMP, HCV, Plavix, daclatasvir, daklinza, ge
A key advisory committee for the European Medicines Agency has given its approval to six new drugs at its latest meeting.
Among those receiving the thumbs-up from the Committee for Medicinal Products for Human Use (CHMP) is Bristol-Myers Squibb’s Daklinza, in combination with other treatments for chronic hepatitis C virus (HCV) infection in adults.
The EMA is now likely to rubber-stamp the approval of Daklinza (daclatasvir), which would make it the EU’s first all-oral and ribavirin-free investigational regimen for use in treatment-naïve genotype 1, 2, 3 patients and protease inhibitor treatment failures.
It is a potentially lucrative area for manufacturers: the market for hepatitis C drugs could rise to more than $100 billion over the next decade, according to Bloomberg Industries.
Also on the CHMP’s ticklist is Eli Lilly’s diabetes treatment Abasria (insulin glargine), the first biosimilar insulin to be recommended for marketing authorisation in Europe.
Meanwhile, GE Healthcare’s Vizamyl (flutemetamol [18F]) was recommended by the CHMP for the visual detection of amyloid-beta neuritic plaques in the brain – an area which has been a focus of R&D into Alzheimer’s disease.
ViiV Healthcare’s HIV treatment Triumeq (abacavir sulfate/dolutegravir sodium/lamivudine) was also shown the green light, and there was a positive opinion for Vifor Fresenius’ Velphoro (mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) for the control of serum phosphorus levels in patients with end-stage renal disease.
The committee also recommended granting a marketing authorisation for Teva Pharma’s Clopidogrel/Acetylsalicylic acid Teva for the prevention of atherothrombotic events – clopidogrel is the active ingredient in Sanofi’s Plavix, which is now off-patent.
The CHMP has also said PARI Pharma’s application for its hybrid medicine Vantobra (tobramycin), to manage chronic pulmonary infection, was adopted via written procedure before the meeting.
Meanwhile, Roche has asked for a re-examination of the CHMP’s refusal in May to extend Avastin’s licence to cover glioblastoma, an aggressive type of brain cancer.
The CHMP also confirmed that Boehringer has withdrawn its marketing application for putative HCV treatment faldaprevir.
Adam Hill
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