Biogen Idec's two-year phase 3 Advance trial of relapsing multiple sclerosis drug Plegridy hit its primary endpoint a year in, reducing the annualized relapse rate of patients taking the drug by 36% compared to a placebo, the company announced this week.
The trial also hit a number of secondary endpoints. Patients on Plegridy showed a 38% less risk of 12-week disability progression as compared to a placebo, the company said. The drug also reduced patient relapses by 39% versus the control group. The full first-year results of the trial also showed significant reduction of MS ailments such as brain lesions.
Plegridy's shown strong safety results so far, with the most serious adverse effects being minor incidents of infections that occurred across all treatment groups.
Gilmore O'Neill, Biogen's Global Neurology Late Stage Clinical Development Vice President, was quoted as saying, "In the first year of the ADVANCE trial, PLEGRIDY demonstrated strong efficacy. We saw a marked reduction in relapse rate and this was supported by MRI results. If approved, PLEGRIDY will make an important therapeutic option in the injectable treatment segment."
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