Brussels, 20/01/2005 (Agence Europe) - In the context of the Full Market Approval (FMA) procedure, twenty “new” medicines obtained FMA granted by the European Commission in 2004, whereas last year in the USA only fourteen medicines obtained FMA. An encouraging result of the European Medicines Agency, which in seven cases gave its approval in the same year as the Federal Drugs Administration (for one of these products, the Commission was unable to grant approval by the end of the year). In other words, half of all the products recently authorised in the USA were authorised over the same period in the EU. Included in the seven other products is the bronchodilator, approved in Europe in 2002 and an antibiotic (telithromycine) authorised in July 2001. The five others involve the treatment of (1) hyperactive bladder, (2) facial skin restoration for certain HIV patients, (3) oral mucosites (an inflammation of buccal and digestive mucous membranes that appears very often after the beginning of the treatment of cancer patients (chemotherapy and radiotherapy), (4) age-related leaky macular degeneration (5) myelodysplastic syndromes, which appear in certain forms of cancer.
The six medicines authorised for the first time in the EU and USA in 2004 will be sued for treating different sorts of cancer (Alimta produced by Eli Lilly; Erbitux produced by ImClone Systems/BMS/Merck; Mimpara produced by Amgen), fort diabetes (Apidra produced by Aventis), for depression (Cymbalta produced by Eli Lilly/Boehringer Ingelheim, which contains an active substance “duloxetine”, also authorised for treating pain caused by diabetic neuropathy under the brand name “Ariclaim” for treating urinary incontinence) and “Emselex” for urinary incontinence (Novartis). At the beginning of January the Commission had still not adopted the decision authorising Avastin (produced by Genentech/Roche) for treating certain forms of colorectal cancer, although a decision in its favour was made by the London agency in October 2004.
The EMEA has also authorised five medicines that have not yet been submitted to the FDA or evaluated by the US agency: - the anti-cholera vaccine, Dukoral by SBL Vaccin; - Levemir by Novo Nordisk for treating diabetes; - the anti-epileptic drug Lyrica by Pfizer, also used in the treatment of peripheral neuropathic pain and in some nervous disorders; - Protelos by Servier, for treating post-menopausal osteoporosis; - Xagrid by Shire Pharmaceutical, for treating the reduction of blood platelettes for patients in danger of thrombocyte.
In nine cases, the European agency has caught up on the FDA: - Zevalin (Schering by AG/IDEC Pharmaceuticals) for treating follicular non-Hodgkin's lymphoma B, authorised in February 2002 by the FDA; - Bondenza (Roche) for the prevention and treatment of menopausal women suffering from osteoporosis, authorised in May 2003; - Reyataz (BMS) for the treatment of HIV-1, authorised in the USA in June 2003; - Cholestagel (Genzyme) for hyper cholesterol levels authorised in May 2000 by the FDA; - Velcade (Janssen-Cilag/Millenium Pharmaceuticals) for the treatment of multiple myloma, authorised in May 2003; - Abiliby (BMS/Otsuka) for schizophrenia, authorised in November 2002; - Telzir (GSK), another anti-retroviral for HIV-1, authorised in October 2003; - Angiox (The Medicines Company), an anticoagulant authorised in the USA in December 2000; - Raptiva (Serono/Genentech) for treating psoriasis, authorised by the FDA in October 2003.