Two new multiple sclerosis (MS) drugs are closer to getting government approval, providing hope for the millions suffering from this debilitating disease, and giving Biogen Idec (NASDAQ:BIIB) a dominant hold on the medications used to treat it.
The Massachusetts-based pharmaceutical company says that midway through a two-year phase III study, its experimental MS drug peginterferon beta-1a (to be marketed under the brand name Plegridy) reduced the annual relapse rate of patients with MS by 36 percent when dosed once every two weeks.
“These full first-year results provide a more complete picture of Plegridy and its positive effects on the reduction of relapse, disability progression and lesion development,” said Peter Calabresi, MD, director, the Johns Hopkins Multiple Sclerosis Center.
“These data suggest that, if approved, Plegridy may offer the benefit of a less frequent dosing schedule, which would be a meaningful advance for people living with MS.”
Plegridy is an injectable drug designed to reduce the dosing schedule of standard interferon drugs such as Biogen’s own Avonex, which are typically dosed at least once a week.
The company says the drug reduced the risk of 12-week disability progression by 38 percent compared with a placebo when given once every two weeks. When given once every four weeks, Plegridy was also shown to be effective, but patients who received the drug once every two weeks responded better.
It also reportedly reduced the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans by 67 percent compared to placebo.
The promising results come on the heels of Biogen being granted a 15-year patent that will help protect the market exclusivity of its other new MS drug, Tecfidera, until 2028. The pill, also known as BG-12, is expected to be approved later this month by the Food and Drug Administration.
The patent covers a dose of two 240-milligram capsules daily for dimethyl fumarate, the active agent for Tecfidera. With only two other MS pills currently on the market, many analysts expect it to become the leading treatment for multiple sclerosis.
The patent will not only hold off the entry of generic competition longer than previously anticipated, but will also prevent the manufacturers of other oral MS drugs from using the same active ingredient at the dosing level Biogen found effective in late-stage clinical trials.
Biogen recently completed negotiations to take control of all of the rights to its other MS drug, Tysabri (natalizumab). The once-monthly, intravenous drug is considered the most effective on the market, but has been linked with a potentially deadly brain infection known as PML (progressive multifocal leukoencephalitis). Last year, sales of Tysabri topped $1.6 billion.
Multiple sclerosis is a chronic condition that occurs when the body’s immune system mistakenly attacks and destroys the protective myelin sheath that protects nerve cells in the brain, optic nerve or spinal cord.
An estimated 400,000 Americans have the disease and more than 2 million worldwide. Symptoms may include loss of balance, difficulty moving arms and legs, weakness, numbness and blindness. There is no known cure.