News round‐up

Abstract Rituximab approved in USA as a new treatment for RA Rituximab, in combination with methotrexate, has been approved by the Food and Drug Administration (FDA) for use in adults with moderate to severe rheumatoid arthritis (RA), who have had an inadequate response to one or more TNF blockers. Rituximab selectively targets CD20‐positive B‐cells, which are believed to contribute to the initiation and development of RA. See rituximab drug profile on page 5. Novel agent for PAH Soon after the launch of sildenafil for pulmonary artery hypertension (PAH), a novel treatment strategy has entered phase III trials. Ambrisentan, an endothelin antagonist manufactured by Myogen, has been shown to improve symptoms and increase exercise capacity in phase II trials ( J Am Coll Cardiol 2005;46:529‐35 ). If the new studies are supportive, marketing authorisation could be sought later this year. Selegiline patch for depression A transdermal formulation of the monoamine oxidase B inhibitor selegiline has received USA FDA approval for the treatment of depression. Emsam, a once‐daily patch, is available in three strengths: 6, 9 and 12mg. Efficacy has been shown in two short‐term trials (6‐8 weeks). No dietary restrictions are necessary for selegiline when it is used to treat Parkinson's disease at a dose of 10mg per day, but the limited data available on the use of the two higher strength patches have not excluded a risk of interaction with tyramine‐rich foods. Patients using the 9 and 12mg patches, therefore, are still being warned to avoid foods rich in tyramine, such as soya bean products. New vaccine prevents shingles and PHN A vaccine to prevent herpes zoster infection and subsequent post‐herpetic neuralgia (PHN) may soon be available. The development follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory committee of the European Medicines Agency. Zostavax, to be marketed in Europe by Sanofi Pasteur MSD, was evaluated in a phase III trial in which it halved the incidence of shingles and reduced PHN by 67 per cent over a median follow‐up of 3 years ( N Engl J Med 2005;352:2271‐84 ). First biological agent for ulcerative colitis The anti‐TNF monoclonal antibody infliximab has become the first biological agent to receive EU approval for the treatment of ulcerative colitis. Licensed as a second‐line agent for moderate to severe disease, infliximab is effective as an induction and maintenance therapy. In two key trials, response rates at 8 weeks were 60‐69 per cent, compared with 29‐37 per cent with placebo, and 44‐45 per cent vs 20 per cent at 54 weeks ( N Engl J Med 2005;353:2462‐76 ). Infliximab was administered as an infusion at 0, 2 and 6 weeks and then every 8 weeks. New treatments for age‐related macular degeneration Following EU approval of the vascular endothelial growth factor (VEGF) inhibitor pegaptinib (Macugen) for neovascular age‐related macular degeneration, an application has been filed for the monoclonal VEGF antibody ramibizumab (Lucentis). Both are administered as intravitreal injections every 4‐6 weeks and act by inhibiting the formation of new blood vessels into the retina, reducing the loss of visual acuity in progressive disease. Novartis combines CCB and A2RA Novartis has filed an application for EU marketing approval for a fixed‐dose combination of the long‐acting calcium channel blocker (CCB) amlodipine and the angiotensin II receptor antagonist (A2RA) valsartan. The new product, Exforge, will be available in a range of strengths and will be targeted both at patients taking drugs separately and those whose blood pressure is not controlled on one of the component drugs. Novartis says the clinical trials showed that combined treatment controlled blood pressure and reduced the incidence of peripheral oedema compared with amlodipine alone. Rotavirus vaccine for infants and toddlers EU approval has been granted for the rotavirus vaccine Rotarix for the prevention of gastroenteritis in young children. The vaccination regimen comprises two doses, which must be given before 24 weeks, and preferably before 16 weeks, of age. It may be administered at the same time as other vaccines currently included in the paediatric immunisation programme. HPV vaccine registered with European regulator The prospect of an effective vaccine against cervical cancer took a step forward in March, when Cervarix was filed for approval in Europe. The manufacturer, GlaxoSmithKline, hopes Cervarix will be available by 2007. In a recent study ( Lancet 2006;367(9518): 1247‐55 ), Cervarix was found to be the first vaccine to be 100 per cent effective in protecting against two strains of HPV that are linked to more than 70 per cent of all cervical cancer cases. Copyright © 2006 John Wiley & Sons, Ltd.