Biogen Idec has just received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) the European Medicines Agency (EMA) for marketing authorization for peginterferon beta-1a, peguilhado interferon administered subcutaneously to adults with multiple sclerosis relapsing-remitting (EMSR).
The CHMP opinion is based primarily on data from the Phase III ADVANCE. Data from the first year of the ADVANCE study showed that peginterferon beta-1a, administered once every two weeks, significantly reduced the annualized relapse rate in 36 percent compared to placebo (p = 0,0007).
Sérgio Teixeira, Biogen Idec Director-Geral da Portugal asserts that "I am delighted that we have received positive opinion from the CHMP and with much anticipation that we await the marketing authorization in the European Union by the EC, after which we can increase the number of therapeutic solutions that provide for the treatment of MS in Portugal ".
"We believe that the beta-1a peginterferon will offer physicians and those living with MS a treatment option that combines efficacy, a profile consistent with the favorable safety class of interferons and dosage administered biweekly ", added.
Following the positive opinion adopted by the CHMP, the decision of the Commission shall be issued in the coming months
For more information on the beta-1a peginterferon, visit biogenidec.com