June 06, 2006
FDA approves resumed marketing of Tysabri under conditional program
An FDA panel said yesterday it would allow Biogen Idec’s multiple sclerosis drug Tysabri back on the market, subject to a restricted distribution program.
The agency ruled that Tysabri can only be prescribed, distributed and infused only by healthcare providers registered with the new program dubbed the “Tysabri Outreach: Unified Commitment to Health (TOUCH) Prescribing Program” by the company.
“This is one of the very rare cases in which a drug withdrawn from the market for safety reasons has been returned to the market, after appropriate steps have been taken,” said Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
Before Tysabri treatment can start, patients must undergo a magnetic resonance imaging (MRI) scan. Then, patients on Tysabri are to be evaluated at three and six months after the first infusion, and every six months after that, with their status being reported directly to Biogen Idec.
TOUCH was developed in conjunction with the FDA to facilitate the appropriate use of Tysabri and to assess the incidence and risk factors for progressive multifocal leukoencephalopathy (PML) associated with Tysabri treatment.
Elements of the TOUCH program include:
*Revised labeling with a prominent boxed warning of the risk of PML and warnings against concurrent use of Tysabri with chronic immunosuppressant therapies, and patients who are immunocompromised due to HIV and other conditions.
*Mandatory enrollment for all prescribers, central pharmacies, infusion centers and patients who wish to prescribe, distribute, infuse, or receive, respectively, Tysabri.
*Controlled, centralized distribution only to authorized infusion centers.
*Mandatory FDA-reviewed educational tools for patients and physicians, including a patient medication guide, TOUCH enrollment form and a monthly pre-infusion checklist.
*Ongoing assessment of PML risk and overall safety.
*A 5,000 patient cohort observational study over five years, the Tysabri Global Observation Program in Safety (TYGRIS).
“Tysabri has demonstrated compelling efficacy in MS, and we believe the TOUCH Prescribing Program, designed in collaboration with the FDA, will help patients and physicians assess the benefits and risks of Tysabri and make informed decisions about therapy," Biogen Idec CEO James Mullen said in a statement.
Euro RSCG Life is agency of record for the drug.
Tysabri was initially approved by the FDA in November 2004, but was withdrawn by Biogen Idec in February 2005, after three patients in the drug's clinical trials developed PML, a serious and rare viral infection of the brain.
Based on this information, FDA put clinical trials of the drug on hold in February 2005. FDA allowed a clinical trial of Tysabri to resume in February 2006, following a re-examination of the patients who had participated in the previous clinical trials, confirming that there were no additional cases of PML.