The multiple sclerosis drug, Lemtrada by Sanofi was rejected by the US Food and Drug Administration. Officials of the FDA stated that there not enough comparative studies to ensure Lemtrada is efficacious in treating MS patients than other medications already on the U.S. market.
Sanofi is a French company which makes another MS prescription medicine, Aubagio, an oral treatment for multiple sclerosis. The pharmaceutical company just acquired Genzyme, which is committed to discovering and delivering transformative therapies for patients with rare and special unmet medical needs. Lemtrada is a twice annual treatment administered through intravenous drip. FDA approval was not given due to the fact that Sanofi representaives did not prove by its drug studies that Lemtrada is more beneficial to the patient than its side effects.
The FDA is concerned about Lemtrada’s possible risks, which include cancer; and autoimmune and thyroid diseases. The drug is supposed to reduce flare-ups of the disease. Multiple sclerosis is an inflammatory condition caused by damage to the insulating covers of the nerves in the brain and spinal cord. The cause of MS is unknown, but some of the symptoms are loss of sensitivity, muscle weakness, problems with speech and swallowing, visual deficiencies and bladder and bowel difficulties.
Sanofi President, David Meeker, was very disappointed in the rejection of the MS drug by the FDA. He stated that the studies completed already were designed to demonstrate how Lemtrada compares against an active competitor as opposed to placebo, and that they provide robust evidence of efficacy and a favorable benefit-risk profile.
The company would need another three years to complete studies that would result in proving that Lemtrada is worth the risk to multiple sclerosis patients.
Sanofi acquired Genzyme in 2011 for the purpose of producing Lemtrada and selling it in the U.S. It was approved this month in the European Union, Australia and Canada. Genzyme was acquired in order to have a bigger footprint in the U.S. drug market. Those who invested in the company were looking forward to profits reflecting the sell of Lemtrada . The European, Australian and Canadian markets are not enough to make a big profit. Multiple sclerosis drugs and treatments are projected to make $20.2 billion a year by 2017.
Some investors hold contingent value rights, or CVR’s, in the drug. That means that they will get a percentage of profits if the drug is accepted by the U.S. FDA by March 30. Shares in Sanofi went down by 1.1 percent on Monday.
Sanofi representatives are not optimistic about getting Lemtrada through the FDA by the end of the March. They will appeal the decision, but precedent does not show much promise.
There is no known cure for multiple sclerosis. Treatments attempt to reduce the effects of an attack and prevent new symptoms from beginning. Medications used to treat MS, while modestly effective, can have adverse effects and be poorly tolerated. The concern for the FDA is that these side effects would be more harmful than Lemtrada’s benefits.
Lemtrada, the multiple sclerosis drug, was rejected by the FDA, and it’s unlikely to be accepted anytime soon.
By Lisa M Pickering