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Home Industry News Biogen Idec’s MS treatment faces extended FDA review

Biogen Idec’s MS treatment faces extended FDA review

20th March 2014

Biogen Idec will be required to wait longer than previously expected for the results of the regulatory review into its Plegridy multiple sclerosis (MS) treatment, the company has revealed today (March 20th).

The US Food and Drug Administration (FDA) has extended the date for the initial Prescription Drug User Free Act application by three months, meaning it will now not give a verdict on whether the treatment is to receive marketing approval until the second half of the year.

Despite the setback, Biogen said it remains confident regarding the treatment, insisting the three month delay is the "standard extension period" and highlighting the fact the FDA has not called for additional studies. As a result, the European filing for the drug remains on track.

Plegridy is a pegylated beta interferon treatment and falls into the same class as the company's older MS drug Avonex. Clinical trial results have indicated it significantly reduces relapses, progression of disability and brain lesions when compared to a placebo.ADNFCR-8000103-ID-801704951-ADNFCR

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