The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use have revealed support for AstraZeneca's nasal spray flu vaccine and expanded approval for Novartis' eye drug Lucentis.
First up, the CHMP has adopted a positive opinion on the Anglo-Swedish drugmaker's Fluenz for the prophylaxis of influenza in children from 24 months to less than 18 years old. The vaccine, which was developed by its MedImmune unit, is already sold in the USA as FluMist.
The committee also gave positive opinions for applications for extensions of three big-selling drugs already authorised in the European Union. Novartis' Lucentis (ranibizumab) has been backed to include the treatment of visual impairment due to diabetic macular oedema, while the label onBristol-Myers Squibb's Sprycel (dasatinib) may include the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in the chronic phase. Pfizer's Sutent (sunitinib) has been recommended to include the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.
The CHMP has also recommended the granting of marketing authorisations for three generics - Pharmathen's version of Roche's Bonviva (ibandronic acid), Actavis' copy of GlaxoSmithKline's Hycamtin (topotecan) and Teva's version of Sanofi-Aventis' Taxotere (docetaxel).
The EMA's advisors have finalised a review of Roche's HIV drug Invirase (saquinavir) following the detection of QT and PR interval prolongation in healthy volunteers. The committee has concluded that ritonavir-boosted Invirase combination treatment "continues to have a positive benefit-risk balance" but has recommended that treatment-naïve patients should take a reduced dose of Invirase during the first week of treatment, as a precautionary measure. Also, the CHMP asked Roche to investigate the potential risk of arrhythmia in treatment-naïve patients receiving the reduced dose of the drug in combination with other antiretrovirals in a new study.
The Committee has also finalised its probe the four fibrates - bezafibrate, ciprofibrate, fenofibrate and gemfibrozil - and concluded that their benefits continue to outweigh their risks in the treatment of patients with blood lipid disorders. However, doctors have been advised not to prescribe them to newly-diagnosed patients with blood lipid disorders as first-line treatment, except for patients with severe hypertriglyceridaemia or patients who cannot take statins.