GlaxoSmithKline and generic companies head the list of beneficiaries from the latest set of opinions issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The CHMP has recommended conditional approval for GSK’s Votrient (pazopanib) for the treatment of advanced renal cell carcinoma and also backed extended use of the firm’s breast cancer drug Tyverb (lapatinib). For full details of the GSK-related opinions, please see tomorrow’s PharmaTimes UK News elert.
Also, the Committee has adopted a positive opinion for Sun Pharmaceutical Industries’ generic of Sanofi-Aventis’ cancer blockbuster Taxotere (docetaxel) but the CHMP had some good news for the French drugmaker, backing the firm’s swine flu vaccine Humenza for approval. The CHMP has also recommended approval of Teva’s version of Eli Lilly’s big-selling osteoporosis drug Evista (raloxifene).
The European regulator has also been told by Genzyme Corp that supply shortages for the firm’s Gaucher disease drug Cerezyme (imiglucerase) and Fabry disease drug Fabrazyme (agalsidase beta) are continuing, following the well-documented problems at its manufacturing facility in the USA. The EMA notes that because the manufacturing difficulties have been on-going since June, it has requested a further inspection of the Allston Landing plant. In more positive news, the CHMP has backed the extension of the label on Genzyme’s Cholestagel (colesevelam) to include combination treatment with Merck & Co’s Zetia (ezetimibe) in patients with primary hypercholesterolaemia.
The Committee has also concluded a review of Johnson & Johnson’s Regranex (bercaplermin), saying that its benefits continue to outweigh the risks for diabetic patients with long-term skin ulcers. However, it recommended to contraindicate Regranex, “as a precautionary measure, in patients who have any pre-existing cancer”.
Finally, the CHMP has begun a review of products containing the non-steroidal anti-inflammatory drug nimesulide because of ongoing concerns over their gastrointestinal and hepatic safety.
