Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

Health Canada Approves Glatiramer Acetate for Clinically Isolated Syndrome Suggestive of MS NEW YORK -- April 17, 2009 -- Health Canada has approved an expanded indication for glatiramer acetate injection (Copaxone) to include the treatment of patients who have experienced a single demyelinating event, accompanied by abnormal magnetic resonance imaging (MRI) scans and are considered to be at risk of developing clinically definite multiple sclerosis (CDMS), after alternative diagnoses are excluded. Adminstering glatiramer acetate to patients who have experienced a single demyelinating event has been shown to delay the onset of definite MS and reduce the number of active brain lesions and overall disease burden identified by MRI scans. The approval is based on the multinational, multicentre, prospective, double-blind, randomised controlled, phase 3 (PreCISEe) study which included a total of 481 patients presenting with a single clinical episode and MRI scans suggestive of MS over a period of up to 3 years. Patients included were those who had a unifocal disease manifestation. Patients were randomised to receive either glatiramer acetate injection 20mg/day or placebo as a subcutaneous injection and continued treatment for up to 3 years, unless a second exacerbation was experienced. Patients who experienced a second exacerbation continued the trial on active treatment for an additional 2 years. The primary efficacy outcome was time to development of second exacerbation. A pre-planned interim analysis was performed on data accumulated from 81% of the 3-year placebo-controlled study exposure. Resutls demonstrated that in the 25th percentile of the patient population, the number of days to second exacerbation was more than doubled by treatment with glatiramer acetate from 336 days to 722 days (hazard ratio [HR] = 0.55; 95% confidence interval [CI], 0.40-0.77; P = .0005), compared with placebo. There was also a significant reduction in the number of new T2 lesions and in the volume of T2 lesions in the glatiramer acetate arm compared with the placebo arm, as measured by MRI scnas following 29 months of therapy. Glatiramer acetate appears to be well tolerated with 84% of patients completing the 3-year study period. SOURCE: CNW Group E-mail this page to a friend or colleague! To print, use this version