The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use was dominated by the suspension of GlaxoSmithKline’s Avandia but there was better news for AstraZeneca and Novartis.
The CHMP is backing the Anglo-Swedish drugmaker’s oral bloodthinner Brilique (ticagrelor), filed in the USA as Brilinta, for the prevention of atherothrombotic events in adults with acute coronary syndrome. The positive opinion was reached after a review of the 18,642-patient PLATO, study which compared the drug with Sanofi-Aventis/Bristol-Myers Squibb’s Plavix (clopidogrel).
Novartis’ Tobi Podhaler (tobramycin) was recommended for approval for chronic pulmonary infection in patients with cystic fibrosis and the company’s prepandemic influenza vaccine Aflunov. The label on the Swiss major’s cancer drug Tasigna (nilotinib) should now be extended to include the treatment of adults with newly-diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia.
Although GSK has been told by the agency that Avandia (rosiglitazone) will not be marketed any more, the UK firm received better news about its influenza vaccine Pandemrix. The CHMP has concluded that the available evidence is insufficient to determine whether there is any link between the vaccine and reports of narcolepsy.
The EMA also revealed that it has started a review of Avastin (bevacizumab), in view of the results of a study conducted by Roche and submitted in support of an application for the blockbuster as a treatment for breast cancer in combination with anthracycline-based or capecitabine cytotoxic chemotherapy. However it noted that in comparison to results of previous trials, “this study points to inconsistencies between different trials relevant for the currently approved breast cancer indication, particularly in terms of efficacy”.
Finally, the CHMP has recommended that the licence for Octopharma’s immunoglobulin treatment Octogam be suspended and all product currently on the market should be recalled. The decision has been taken “after an unexpected increase in reports of thromboembolic reactions, including stroke, heart attack and pulmonary embolism in patients receiving the medicine”.
