The approval covers the reintroduction of Tysabri (natalizumab) as a monotherapy treatment for relapsing forms of multiple sclerosis (MS) to slow the progression of disability and reduce the frequency of clinical relapses.
The FDA granted the approval for reintroduction based on a review of Tysabri clinical trial data, revised labeling with enhanced safety warnings, and a risk management plan designed to inform physicians and patients of the benefits and risks of Tysabri treatment and minimize potential risk of progressive multifocal leukoencephalopathy (PML).
Due to the increased risk of PML, Tysabri monotherapy is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies.
The regulator’s decision also follows a March 8, 2006 unanimous recommendation by the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee to allow the reintroduction of Tysabri.
Tysabri will be available upon the completion of key activities related to the risk management plan, including an FDA review of educational and training materials, internal validation of systems based on final FDA requirements and training of internal personnel. As such, the companies anticipate that Tysabri will be available in July.