U.S. health regulators have given the go signal for a new drug developed by Massachussetts-based biotechnology company Biogen Idec, Inc. for patients with multiple sclerosis. On Friday, the Food and Drug Administration approved the use of Plegridy for patients with relapsing form of multiple sclerosis or RMS providing a new treatment option for those who suffer from the condition.
It is estimated that multiple sclerosis, a chronic and disabling disease that affects the nervous system, affects over 2.3 million people globally. In the U.S. the number of individuals believed to be battling the condition is no lesser than 400,000. The disease is marked by symptoms that range from as mild as numbness in the limbs to more severe such as loss of eyesight and paralysis.
Similar to Biogen's older multiple sclerosis drug Avonex, Plegridy belongs to the interferon class of medicines but unlike Avonex, which needs to be injected once per week, the new drug is designed to be administered once in two weeks. Plegridy is also injected subcutaneously instead of intramuscularly which means that the new drug requires a smaller needle.
"PLEGRIDY offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments," Biogen Idec CEO George Scangos said. "PLEGRIDY represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them."
The new drug which was green-lighted based on the promising results of the two-year clinical study ADVANCE, one of the biggest studies conducted on interferon that assessed the safety and effectiveness of Plegridy when administered subcutaneously. Common adverse reactions associated with use of Plegridy include fever, flu-like illness, muscle pain, pain and itching on the injection site, chills, weakness and joint pain.
Biogen expects Plegridy to eventually replace its older best seller Avonex albeit the company said that support will continue for the older drug, which had made a global sales of over $1.5 billion in the first half of this year alone, as there are patients who are more comfortable with this treatment and do not plan to make a switch.
The company also expects the new drug to affect other multiple sclerosis drugs on the market.
"We believe Plegridy has the potential to be the leading interferon on the market," Biogen's head of global commercial operations Tony Kingsley said. "The most convenient product wins over time."
