Elan and Biogen Idec allowed by FDA to reintroduce Tysabri

Irish pharmaceutical company Elan and Biogen Idec have announced that the FDA has approved the reintroduction Tysabri, after it was voluntarily withdrawn by the companies following reports of rare but possibly fatal side effects.

Tysabri, a treatment for relapsing forms of multiple sclerosis (MS), was suspended from clinical trials and marketing in the US after there appeared to be an increased risk of developing PML, a type of usually-fatal brain virus, in users of the drug.

However, following the introduction of revised labelling to warn of the risks, controlled distribution of the drug and a start of a five year safety study of the effects of the drug in over 5,000 patients, the FDA approved the reintroduction of the drug.

James C Mullen, Biogen Idec’s chief executive officer, remarked: “Today represents a significant step forward for people with relapsing MS.”

“The reintroduction of Tysabri offers new hope as an important therapeutic choice for patients living with this disabling disease,” he added.

Elan’s chief executive, Kelly Martin, concluded: “There continues to be a significant unmet medical need where Tysabri will be an important treatment option.”

Reuters said Elan shares fell 12 per cent yesterday with news due to the restrictive nature of the FDA’s approval of the drug. The American regulator said that patients must enrol in a programme to receive the Tysabri and must report their findings to the drug’s manufacturers.

Multiple sclerosis affects approximately 85,000 people in the UK, according to the Multple Sclerosis Society. The disease is caused by damage to the myelin sheaths coating the body’s nerves, meaning that electrical nerve impulses required for movement are not transmitted effectively or accurately.

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