FDA Panel to Discuss Re-Approval of Multiple Sclerosis Drug Tysabri

Strategic Insights -

A US Food and Drug Administration (FDA) advisory panel is set to discuss the potential re-approval of the multiple sclerosis drug Tysabri, also known as natalizumab, which has been linked to a rare brain disease and other infections. The panel will examine the risks and benefits of the drug, which was voluntarily withdrawn in 2005 after three patients developed progressive multifocal leukoencephalopathy (PML), a usually fatal brain disease. Pharmaceutical companies Biogen Idec and Elan Corporation are seeking permission to resume selling the drug, citing its benefits for patients with relapsing multiple sclerosis.

Key Takeaways:

  • The FDA advisory panel will discuss whether to permit Tysabri's return to the market, despite concerns about its link to PML and other infections.
  • The drug was voluntarily withdrawn in February 2005 after three patients developed PML, two of whom died, out of approximately 7,000 patients who received it.
  • The FDA staff remains skeptical about which patients could safely use the drug due to the risk of PML.
  • F.D.A. officials want to strengthen and make mandatory a risk-management plan to guard against P.M.L. cases.
  • The drug is administered intravenously once a month and is the first treatment to slow the progression of multiple sclerosis, a disease affecting about 350,000 Americans with no known cure.

Statistics:

  • 3 patients developed PML out of approximately 7,000 patients who received Tysabri in four months.
  • 2 of the 3 patients who developed PML died.
  • 350,000 Americans are afflicted with multiple sclerosis, a disease of the central nervous system with no cure.
  • Tysabri was administered intravenously once a month.

Sources:

  • "Advisors to F.D.A. to Review Multiple Sclerosis Drug", New York Times, Monday, [date not specified].
  • F.D.A. documents released before a meeting of the agency's advisory committee on peripheral and central nervous system drugs.