Multiple Sclerosis Drug Delayed by FDABy: Mike Fossum - March 23, 2014
Biogen Idec Inc. has stated that the U.S. Food and Drug Administration extended the review process its multiple sclerosis drug called Plegridy by three months to evaluate the application, though the FDA didn’t request any further studies. Biogen had planned to launch the new drug sometime in mid-2014, but is now delayed.
Plegridy is an injectable medication designed to reduce the dosing schedule of standard interferon drugs like Biogen’s own Avonex, which are typically taken at least once a week. Interferon has intense side effects, leading to flu-like symptoms for a couple of days after each dose, causing some patients to be weary to continue treatment.
According to Biogen, Plegrity (peginterferon beta-1a) is a pegylated compound derived from interferon beta-1a and is being investigated as a potential treatment dosed once every two weeks or every four weeks via subcutaneous injection for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS).
Multiple sclerosis (MS), also known as disseminated sclerosis or encephalomyelitis disseminata, is an inflammatory disorder in which the insulating covers of nerve cells in the brain and spinal cord become damaged. Communication between parts of the nervous system are affected, which leads to problems with motor skills and cognitive functions. MS can occur in acute attacks, or build up in a progressive form. Symptoms may completely disappear during acute episodes, though permanent neurological damage typically occurs as the disease progresses.
MS was first described by Jean-Martin Charcot in 1868, and has no known cure. Existing drugs aren’t very effective, and the aforementioned side effects can be severe. While the cause is not completely clear, it has been theorized that a compromised immune system mistakenly begins to attack and destroy the protective sheath that envelopes nerve cells in the brain, optic nerve and spinal cord.
It is thought that genetics and environmental factors that had lead to infections cause the onset of the disease.
Image via Wikimedia Commons.