Biogen Idec has posted positive new data for its investigational multiple sclerosis drug Plegridy showing that it can help cut relapse rates over the long term.
The firm has announced the positive, full first-year results from its two-year Phase III ADVANCE study of Plegridy (injectable peginterferon beta-1a), the company’s investigational candidate for relapsing-remitting multiple sclerosis, dosed once every two weeks or every four weeks.
The drug met its primary endpoint of reducing annualised relapse rate at one year by 36%, when compared to placebo, while also reducing the proportion of patients who relapsed by 39%, again compared to placebo.
These data, presented this week at the American Academy of Neurology’s 65th Annual Meeting, suggest the drug can significantly reduced multiple sclerosis disease activity, including relapses, disability progression and brain lesions, compared to placebo at one year.
Gilmore O’Neill, VP of global neurology at Biogen, said the drug had shown “strong efficacy” adding that if it is approved, Plegridy will make an “important therapeutic option” in the injectable treatment segment.
This segment already has established MS drugs, which include Roche’s Pegasus and Copegus, as well as Biogen’s own Avonex and Tysabri. The Phase III trial did not pit Plegridy against any of these medicines, but this may be needed to win over regulators, and HTA bodies.
But the drug may have an edge over these ageing treatments, despite coming to market later, as it requires less injections than its competitors.
There is, however, a new and emerging market for MS pills, which is currently being headed by Novartis’ Gilenya. This drug is touted as a blockbuster, although this has been downgraded seen regulatory concerns over its safety profile were published last year.
Analysts expect the market for interferons like Plegridy to shrink over the next decade as newer generation products, such as Gilenya, become more popular for patients, given their ease of use over injectables.
Biogen is, however, looking to cover both bases, and is also poised to launch a new MS pill in the form of Tecfidera, a drug that many analysts believe could become the leading treatment for the disease given its high success rates in Phase III trials.
