Panel Supports Tysabri Return

An FDA committee says it will recommend that the agency again clear the drug.
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Updated from 4:29 p.m. EST

A Food and Drug Administration advisory panel has unanimously decided to recommend that the FDA allow the multiple sclerosis drug Tysabri to return to the market.

The 12-member panel of medical experts completed a two-day meeting on Tysabri Wednesday. The drug is marketed by

Biogen Idec

(BIIB) - Get Report

and

Elan

(ELN)

, and it was pulled in February 2005 after being linked to a rare brain illness that can be deadly.

Panel members had to discuss what conditions should be met before Tysabri is given to individual patients and how it should be used. Committee members voted 7-to-5 to suggest doctors be permitted to prescribe Tysabri as the first treatment choice for MS patients.

Many Wall Street analysts expected that Tysabri would again be available for sale, but with certain conditions attached. The FDA isn't required to follow the decisions of its advisory panels, but it usually does.

The panel concluded that additional clinical trials weren't necessary for the drug's return. However, if the FDA were to allow re-entry, the drug should be limited to a certain subgroup of MS patients under strict guidelines, the panel said.

Also, according to the advisory committee's suggestions, patients should be tracked by regular surveys given prior to monthly Tysabri infusions. Patients' receipt of the drug would be contingent on Biogen getting the safety reports, which would include any side effects and allergic reactions.

Shares of Elan were halted during the meeting but opened just before the close of regular

New York Stock Exchange

trading. When they did, the buying was fast and furious, as the stock jumped $3.11, or 24.5%, to $15.81. More than 17 million shares changed hands in just under 30 minutes of trading, compared with average volume of 10.7 million shares for a full session during the last three months.

Biogen's shares were also halted while the two-day meeting was taking place, and they resumed trading in after-hours activity, climbing $3.90, or 8.6%, to $49.40.

Meanwhile,

Teva

(TEVA) - Get Report

, the maker of an MS medication called Copaxone, slipped 22 cents to $40.89.

Serono

(SRA)

, which sells the MS drug Rebif, lost 56 cents to $17.32.

The reach of those two products provides an idea of the size of the market Biogen and Elan are hoping to rejoin. Rebif had sales of $1.27 billion last year, and Copaxone sales totaled $1.18 billion in 2005.

On Tuesday, the panel heard emotional testimony from MS patients who say Tysabri succeeded in improving their lives after other treatments had failed. The drug's supporters touched on a common theme -- that they simply want the choice of using Tysabri.

Tysabri was withdrawn after being connected to a disease called progressive multifocal leukoencephalopathy. Two PML cases appeared in patients who took Tysabri for multiple sclerosis along with another Biogen MS treatment, Avonex. A patient who received Tysabri during a Crohn's disease trial was later found to have PML. In two of the cases, the patients died.

Following the PML cases, Biogen and Elan performed a safety evaluation of more than 3,000 Tysabri patients, but found no new confirmed cases of the disease beyond the three that had been reported. Biogen and Elan are equal partners in the drug.

MS is a chronic, debilitating disease that affects the brain and spinal cord. MS is thought to be an autoimmune disease, and while it isn't considered deadly, it can severely compromise a patient's quality of life, possibly leading to numbness, difficulty thinking and coordination and speech problems. People with MS can become severely disabled, but most don't, according to the National Multiple Sclerosis Society.

The society estimates that around 400,000 Americans have the disease, while worldwide about 2.5 million people have MS. Twice as many women have it as men, and most of the diagnoses are made in people age 20 to 50.

The FDA's advisory panel recommended against Tysabri use in combination with other drugs that suppress the body's immune system, but it didn't rule out the possibility of its combination with other medications after further data on the risk of PML are collected and examined.

The panel believes PML is still possible in patients using Tysabri alone to treat MS and says more cases of the brain disease could surface and that more deaths could be reported. Still, other approved and widely used medications are known to have dangerous side effects, as well, the panel noted.

Biogen plans to follow up with patients on Tysabri if the drug gains the FDA's reapproval, saying everyone who takes it would be tracked to determine how many adverse incidents occur.

Additionally, Biogen said Tuesday it would query physicians after six months and track patient deaths through a national index and a collection of death certificates.

Elan and Biogen expect to follow 5,000 patients to monitor for side effects or serious infections. Biogen has said it would support Tysabri having a "black box warning," the FDA's strictest cautionary statement, outlining the risk of PML and saying that the drug shouldn't be used with other treatments for MS.

The FDA has granted Tysabri priority review, a status applied to drugs seen as significant advancements over existing therapies. Biogen and Elan say they will continue to work with the FDA on the details of a risk-management plan, and they expect a decision from the agency by March 29.