The positive opinion is for Tysabri (natalizumab) as a treatment for relapsing-remitting multiple sclerosis (MS) to delay the progression of disability and reduce the frequency of relapses.
The committee recommended that Tysabri be used as single disease modifying therapy either in patients with highly active relapsing-remitting MS who have failed to respond to treatment with a beta-interferon, or in patients who have rapidly evolving severe relapsing-remitting MS.
In making its recommendation, the Committee for Medicinal Products for Human Use (CHMP) reviewed available data from the development of Tysabri, including data from the phase III AFFIRM monotherapy trial, the phase III SENTINEL trial in which Tysabri was added to Avonex (interferon beta-1a); and a comprehensive safety analysis, which included the assessments for cases of progressive multifocal leukoencephalopathy (PML).
The CHMP also reviewed a risk management plan to assess and minimize risks, including PML and other serious opportunistic infections.
The CHMP’s positive recommendation for Tysabri will be considered for final marketing approval by the European Commission. Final approval customarily follows the CHMP’s recommendation, which the companies anticipate will be this summer.