Biogen, Elan expect data, prescription program to advance Tysabri reintroduction

By Jennifer Lanning Drey

Eugene, Ore., June 6 - Biogen Idec and Elan Corp. plc expect Tysabri's (natalizumab) efficacy data and new prescription program to help advance the drug once it is reintroduced to the U.S. market, according to officials from both companies.

The Food and Drug Administration announced Monday that it had approved the two companies' supplemental Biologics License Application for the reintroduction of Tysabri as a monotherapy treatment for relapsing forms of multiple sclerosis.

"With a powerful efficacy and the current disenchantment with the existing treatments, we believe Tysabri, over time and with a fuller understanding of its long term safety profile, will find its appropriate place in the treatment of MS," said Bob Hamm, senior vice president for the neurology business unit at Biogen, during a company conference call held Tuesday.

Two-year data from a monotherapy trial showed that treatment with Tysabri reduced the risk of disability progression in multiple sclerosis patients by 42% and led to a 67% reduction in the annualized relapse rate compared to a placebo, according to a company news release.

"We believe appropriate patients can benefit from Tysabri given its outstanding efficacy, and we will work diligently to provide physicians and patients with information about the risks and benefits of Tysabri so they can make informed decision about their MS therapy," said Jim Mullen, chief executive officer of Biogen, during Tuesday's conference call.

Biogen and Elan voluntarily suspended Tysabri and ongoing clinical trials in the United States in February 2005 based on reports of progressive multifocal leukoencephalopathy in three clinical trial patients, according to a joint company news release.

In conjunction with Tysabri's reintroduction, Biogen and Elan will begin the Tysabri Outreach: Unified Commitment to Health (Touch) prescribing program, which they designed with the FDA to facilitate appropriate use of the drug.

"We must remember that 16 months later, from the original launch, we have a lot more information now," Hamm said.

Biogen and Elan said they also expect to launch Tysabri in most European markets in 2007.

Biogen Idec is a Cambridge, Mass., biopharmaceutical company focused on oncology, neurology and immunology.

Elan is a Dublin, Ireland, neuroscience-based biotechnology company.

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