Natalizumab (Tysabri) for the Treatment of Multiple Sclerosis in Canada
On October 5, Health Canada approved natalizumab intravenous infusion (Tysabri, made by Biogen Idec and Elan Corporation, plc) as monotherapy to delay the progression of disability, reduce the frequency of relapses, and to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) in patients with relapsing-remitting multiple sclerosis (MS). The drug is intended for use in patients with high disease activity despite treatment with a beta-interferon and in those with rapidly evolving severe disease.
The Canadian approval was based primarily on data from the 2-year, randomized, multicenter, double-blind Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study of 942 patients showing that use of natalizumab decreased the rate of clinical relapses by 68% and the risk for MS-related sustained disability progression by 42% compared with placebo (P < .001 for both). Natalizumab therapy also yielded sustained and statistically significant reductions in brain lesion activity as measured by MRI.
Natalizumab has been linked to an increased risk for progressive multifocal leukoencephalopathy (PML); cases have included patients who received the drug for more than 2 years or who received intermittent doses over an 18-month period. In clinical trials, 2 cases occurred in 1869 patients with MS who had been treated for a median of 120 weeks; a third case occurred among 1043 patients with Crohn's disease after the patient had received 8 doses. All 3 patients had received concomitant treatment with immunomodulators (eg, interferon beta) or were immunocompromised due to immunosuppressant therapy (eg, azathioprine).
According to a company news release, patients receiving natalizumab therapy are encouraged to enroll in the TYSABRI Care Program, which ensures that appropriate physicians and infusion centers are able to prescribe or infuse the product. The comprehensive program is intended optimize treatment through improved compliance, standardize infusion treatment at clinics, support safety through rigorous education and ongoing surveillance, and provide reimbursement and patient support to ease the administrative burden associated with therapy.
Natalizumab was previously approved by the US Food and Drug Administration and the European Commission in November 2004 and June 2006, respectively, as monotherapy to delay the progression of disability and reduce the frequency of relapses in MS patients.
Although natalizumab was withdrawn from the US market in February 2005 due to concern regarding the potential associated risk for PML, it was reintroduced in June 2006 with labeling revisions and a restricted distribution program (TYSABRI Outreach: Unified Commitment to Health [TOUCH]) after a comprehensive safety evaluation (N > 3000) yielded no new cases of the disease.
Multiple Sclerosis (MS)
http://www.medscape.com/viewarticle/546424
The Canadian approval was based primarily on data from the 2-year, randomized, multicenter, double-blind Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study of 942 patients showing that use of natalizumab decreased the rate of clinical relapses by 68% and the risk for MS-related sustained disability progression by 42% compared with placebo (P < .001 for both). Natalizumab therapy also yielded sustained and statistically significant reductions in brain lesion activity as measured by MRI.
Natalizumab has been linked to an increased risk for progressive multifocal leukoencephalopathy (PML); cases have included patients who received the drug for more than 2 years or who received intermittent doses over an 18-month period. In clinical trials, 2 cases occurred in 1869 patients with MS who had been treated for a median of 120 weeks; a third case occurred among 1043 patients with Crohn's disease after the patient had received 8 doses. All 3 patients had received concomitant treatment with immunomodulators (eg, interferon beta) or were immunocompromised due to immunosuppressant therapy (eg, azathioprine).
According to a company news release, patients receiving natalizumab therapy are encouraged to enroll in the TYSABRI Care Program, which ensures that appropriate physicians and infusion centers are able to prescribe or infuse the product. The comprehensive program is intended optimize treatment through improved compliance, standardize infusion treatment at clinics, support safety through rigorous education and ongoing surveillance, and provide reimbursement and patient support to ease the administrative burden associated with therapy.
Natalizumab was previously approved by the US Food and Drug Administration and the European Commission in November 2004 and June 2006, respectively, as monotherapy to delay the progression of disability and reduce the frequency of relapses in MS patients.
Although natalizumab was withdrawn from the US market in February 2005 due to concern regarding the potential associated risk for PML, it was reintroduced in June 2006 with labeling revisions and a restricted distribution program (TYSABRI Outreach: Unified Commitment to Health [TOUCH]) after a comprehensive safety evaluation (N > 3000) yielded no new cases of the disease.
Related Links
Resource Centers
Hepatitis BMultiple Sclerosis (MS)
http://www.medscape.com/viewarticle/546424
posted by Bill at 6:05 PM
0 Comments:
Post a Comment
<< Home