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Spokane, Washington  Est. May 19, 1883

FDA allows MS drug’s return to market

Andrew Bridges Associated Press

WASHINGTON – A multiple sclerosis drug pulled from the market last year because of a rare but life-threatening side effect will return under a restricted distribution program, health officials said Monday.

The Food and Drug Administration said it will let Biogen Idec Inc. and Elan Corp. PLC resume selling Tysabri (pronounced ty-SAH-bree) under a requirement that doctors, pharmacies and patients register with a program designed to ensure the safe use of the drug.

Tysabri received FDA approval in November 2004. Biogen Idec, its Cambridge, Mass.-based manufacturer, voluntarily withdrew it in February 2005 after two patients in clinical trials died of a rare brain infection called progressive multifocal leukoencephalopathy, or PML. Ireland-based Elan distributes the drug, also called natalizumab.

Only one other prescription drug, the irritable bowel treatment Lotronex, has ever returned to the market after being pulled because of dangerous side effects.

The FDA said Tysabri is to be used alone in patients who did not respond “adequately” to – or cannot tolerate – other MS drugs. Previously, some doctors prescribed it with Avonex, also made by Biogen Idec.

Researchers have estimated as many as one in every 1,000 Tysabri users might fall prey to the virus that causes PML.

“We expect, yes, that there will be other cases and, yes, there will be additional deaths. This is balanced against the significant benefit we believe the drug confers,” said Dr. Russell Katz of the FDA’s Center for Drug Evaluation and Research.

The drug’s label will bear a severe “black-box” warning of the risk of PML, which also occurs in other drugs that suppress the immune system.

MS patients supported the return of Tysabri, despite its risks.

“The benefits, No. 1, are worth it. No. 2, I am not afraid of dying I am afraid of living with the disease and being a burden to my family,” said Barbara Crooks, 48. The retired magnetic resonance imaging technologist from Irwin, Pa., took the drug for three months before its withdrawal.

Elan and Biogen Idec said Tysabri could be available as early as July, following an FDA review of elements of the risk management plan for the drug. Its price hasn’t been set.

“The reintroduction of Tysabri offers new hope as an important therapeutic choice for patients living with this disabling disease. Tysabri has demonstrated compelling efficacy in MS,” said James Mullen, Biogen Idec’s chief executive officer.

The once-a-month intravenous drug is meant to treat patients with relapsing MS to reduce the frequency of flare-ups, which can complicate walking and sight.

Beyond PML, for which there is no cure, Tysabri’s side effects include allergic reactions and an increased risk of unusual or serious infections, according to the FDA.