Peginterferon beta-1a has been approved by the Food and Drug Administration for treating relapsing forms of multiple sclerosis, based on the results of the ADVANCE trial, the manufacturer, Biogen Idec, announced on August 15.
This is the only pegylated interferon approved for treating relapsing MS, according to a statement from the company.
Biogen Idec will be marketing the drug as Plegridy. The recommended dose is 125 mcg administered subcutaneously every 14 days. It can be administered with a prefilled syringe or a new autoinjector the company is marketing as the Plegridy Pen, according to the statement.
The approval is based on the results of the ADVANCE study, a randomized, double-blind, phase III, 2-year study of about 1,516 patients with relapsing MS, which was placebo-controlled during the first year. The annualized relapse rate, the primary outcome, was reduced by 36% among those treated with peginterferon beta-1a, compared with those on placebo, a statistically significant difference.
Secondary outcomes including the proportion of patients who relapsed, which was reduced by 19%, compared with placebo; the mean number of new or newly enlarging T2 hyperintense lesions, which was reduced by 67%, compared with placebo; and the mean number of new gadolinium-enhancing lesions, which was reduced by 86%, compared with placebo.
Injection-site erythema, influenzalike illness, fever, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia were the most common adverse events associated with treatment, affecting at least 10% of treated patients and occurring at a rate that was at least 2% greater than among those on placebo, according to the prescribing information.
Postmarketing studies that the company will be required to conduct include a pediatric study and a registry study in the United States that will compare the maternal, fetal, and infant outcomes, including birth defects, of women with MS who are treated with peginterferon beta-1a during pregnancy against women with MS who are not treated with the drug during pregnancy and women who do not have MS.
The product has already been approved in Europe.
Serious adverse events associated with this product should be reported to the FDA at 800-332-1088 or www. fda.gov/medwatch.
emechcatie@frontlinemedcom.com