The European Commission granted marketing authorization for the use of Plegridy, a drug developed by Biogen Idec as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). The approval comes at a time when another Biogen Idec MS treatment, Tecfidera, is being established as an MS treatment option and boasting impressive sales, boosting the company’s shares by 11 percent.
Data from recent clinical trials conducted by Biogen Idec to test Plegridy were the impetus for the European Commission approval, as they assure drug safety and effectiveness, following a positive consideration from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. During the Advance1 study, one of the largest pivotal studies of a beta interferon therapy ever performed, it was demonstrated that the injectable therapy significantly reduces some of the disease parameters of activity, such as number of relapses, MRI brain lesions, and disability progression.
The Plegridy medication is administered once every two weeks subcutaneously, using a Plegridy Pen, which is a new ready-to-use autoinjector, or a pre-filled syringe, and it is considered a major innovation, since Plegridy is the only pegylated interferon approved to treat RRMS and allows patients to undergo a less frequent dosing schedule.
“Plegridy offers people living with MS an interferon with compelling efficacy that requires considerably fewer injections than other platform therapies,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “The approval of Plegridy demonstrates our commitment to improving the lives of patients by providing innovative therapies that meet their individual needs, including flexibility in managing their disease.”
Advance1 clinal trials included more than 1,500 patients with relapsing forms of MS, which were dosed either with Plegridy once every two weeks, or placebo. The results demonstrated significant reductions on annualized relapse rate (ARR) at one year by 36 percent, compared to the group who was administrated with placebo. The Biogen Idec drug also reduced the risk of sustained disability progression by 38 percent when analyzed at twelve weeks, and by 54 percent at twenty four weeks. The number of gadolinium-enhancing lesions decreased in 86 percent, compared to placebo.
“The safety and efficacy that Plegridy has demonstrated, combined with its less frequent dosing schedule offers MS patients an option to put their treatment in the background for longer stretches of time,” said Professor Bernd C. Kieseier, M.D., Heinrich-Heine Universität, Dusseldorf.
“These are spectacular results, and this is one of the biggest profit beats for Biogen I’ve seen in years,” said RBC Capital Markets analyst Michael Yee to Ransdell Pierson from Reuters, as Biogen’s shares have recently increased by 11 percent. The drug was approved in March 2013 in the United States and represented $700 million in sales during the second quarter of the year to the company, becoming one of the fastest-growing medications in the United States.
“Tecfidera has the best balance of efficacy and safety” compared to the three oral agents of the company, explained the Robert Baird and Co analyst Chris Raymond, who explained that it could become the oral treatment of choice for MS patients and their physicians and reach annual sales up to $6 billion. Tecfidera costs approximately $48,000 a year in the United States and about $30,000 in Europe.
Despite the fact that it has previously given a preliminary negative opinion, the UK’s National Institute for Health and Care Excellence (NICE) had recently turned back and given a positive final appraisal determination to the use of Tecfidera in adults with relapsing-remitting multiple sclerosis (RRMS).