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The Food and Drug Administration review of a pegylated interferon for multiple sclerosis has been extended by 3 months, according to the manufacturer.
A statement issued by Biogen Idec on March 18 said that the agency had extended the Prescription Drug User Fee Act (PDUFA) date for the product’s review by 3 months, "to allow additional time for review of the application." The agency is not requesting additional studies, the statement said.
The product is a subcutaneously administered formulation of pegylated interferon beta-1a for treating relapsing forms of MS. If the agent is approved, Biogen plans to market it as Plegridy.
In the ADVANCE trial of about 1,500 patients with relapsing-remitting MS, treatment with this pegylated interferon administered every 2 weeks was associated with statistically significant advantages for all clinical and radiologic outcomes, compared with placebo, over 1 year.
The product is also being reviewed in Europe for the same indication.
The Food and Drug Administration review of a pegylated interferon for multiple sclerosis has been extended by 3 months, according to the manufacturer.
A statement issued by Biogen Idec on March 18 said that the agency had extended the Prescription Drug User Fee Act (PDUFA) date for the product’s review by 3 months, "to allow additional time for review of the application." The agency is not requesting additional studies, the statement said.
The product is a subcutaneously administered formulation of pegylated interferon beta-1a for treating relapsing forms of MS. If the agent is approved, Biogen plans to market it as Plegridy.
In the ADVANCE trial of about 1,500 patients with relapsing-remitting MS, treatment with this pegylated interferon administered every 2 weeks was associated with statistically significant advantages for all clinical and radiologic outcomes, compared with placebo, over 1 year.
The product is also being reviewed in Europe for the same indication.
The Food and Drug Administration review of a pegylated interferon for multiple sclerosis has been extended by 3 months, according to the manufacturer.
A statement issued by Biogen Idec on March 18 said that the agency had extended the Prescription Drug User Fee Act (PDUFA) date for the product’s review by 3 months, "to allow additional time for review of the application." The agency is not requesting additional studies, the statement said.
The product is a subcutaneously administered formulation of pegylated interferon beta-1a for treating relapsing forms of MS. If the agent is approved, Biogen plans to market it as Plegridy.
In the ADVANCE trial of about 1,500 patients with relapsing-remitting MS, treatment with this pegylated interferon administered every 2 weeks was associated with statistically significant advantages for all clinical and radiologic outcomes, compared with placebo, over 1 year.
The product is also being reviewed in Europe for the same indication.
