The Massachusetts-based biotechnology company got the Food and Drug Administration (FDA) approval to sell the drug on Wednesday and the company confirmed that the oral drug will be available to patients from Monday.
Tony Kingsley, executive vice president, commercial operations, Biogen Idec, said, “We think it’s an appropriate price. The clinical benefit of the product is very meaningful. We look at it in comparison to the alternatives on the market and the investment we’ve made.”
The company would over the next few months talk about the clinical benefits of the drug with commercial and government insurers and tell them how the drug had the potential to cure MS patients without any visits to the hospital.
Thumbs up for MS cure
The oral drug is in no time going to become a top seller as clinical trials of the drug showcased that it effectively reduced the disease over a period of two year. Among the most common side-effects of the drug were stomach problems, nausea, diarrhea and others but these too reduced over time.
Russell Katz, director, Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said “No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients.”
He added that Multiple sclerosis could impair movement, sensation and thinking and have a profound impact on a person’s quality of life and as such the drug came as a life saver for the people suffering from this disease.
Details on MS
Multiple Sclerosis is a chronic ailment that affected the central nervous systems of about 400,000 people in the US and about 2.5 million globally and disrupted the ability of the brain to communicate with the body.
“Tecfidera has demonstrated greater safety and effectiveness than competing pills. Biogen Idec sponsors patient assistance programs to help pay for the drugs in cases where all or part of the cost is not covered by private or public payers,” said a company statement.
Biogen’s two other drugs Avonex and Tysabri are currently priced at $50,880 and $52,449. Another MS treatment, Copaxone, sold by Israel’s Teva Pharmaceutical Industries Ltd, is priced at about $56,000.
“Now that Biogen Idec has determined the price of Tecfidera, it can move forward with distributing the drug. We’re days away from getting the product to patients, which we’re very excited about,” Kingsley added.