Monday, June 16, 2014

Biogen, AbbVie drug slows MS episodes, safety issues recur


Credit: Reuters/Brian Snyder


A pedestrian passes the sign outside the headquarters of Biogen Idec Inc. in Cambridge, Massachusetts June 18, 2008.


The mixed results were seen in a Phase III international study of the medicine, called daclizumab, that involved more than 1,800 patients with relapsing-remitting multiple sclerosis - the most common form of MS which can lead to disability and paralysis.


The companies disclosed partial results from the new trial on Monday. Shares of both Biogen and AbbVie were little changed in morning trading.


In the study, called DECIDE, once-monthly injections of daclizumab were tested against once-weekly injections of Biogen's blockbuster Avonex (interferon beta-1a) treatment for MS.


Patients taking daclizumab, which is meant to tame the immune system by blocking a protein called the CD25 receptor, had 45 percent fewer annual relapses than those receiving Avonex. Moreover, patients taking daclizumab had 54 percent fewer new or enlarging brain and spinal lesions at week 96 of the study, compared to those taking Avonex, thereby meeting a secondary goal of the study.


The overall incidence of side effects was similar in both patient groups. But there was a two-fold higher incidence of serious infections among those taking daclizumab, at 4 percent, as well as a two-fold higher incidence of elevated liver enzymes - a potential marker for liver toxicity.


Daclizumab would be a new approach to treating MS, if it is approved for the condition.


Biogen and AbbVie said they would discuss with health regulators timing for potential marketing applications for the drug.


MS is believed to be caused by overactive immune system cells, called t-cells, that attack and destroy the protective covering of nerves.


(Reporting by Ransdell Pierson; Editing by Nick Zieminski)


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