The US Food and drug administration has rejected a multiple sclerosis drug, Lemtrada by Sanofi. The reason for the rejection is that officials of the FDA stated that there were not enough comparative studies that ensure the Lemtrada is effective in treating MS patients than other medications that are already available on the U.S. market.
Sanofi is a French company, which currently makes another multiple sclerosis drug, Aubagio, which is taken orally for MS. The pharmaceutical company just acquired Genzyme, which is committed to discovering and delivering transformative therapies for patients with rare and special unmet medical needs per Liberty Voice. Lemtrada differs from Aubagio in that it is a twice-annual treatment administered through intravenous drip. Sonafi representatives did not prove by its drug studies that Lemtrada is more beneficial to the patient than its side effects that can come, which is why the FDA did approve of the medication.
The FDA voiced concerns about Lemtrada’s possible side effects, which include cancer as well as autoimmune and thyroid diseases. The drug is designed to reduce MS flare-ups.
Multiple sclerosis is an inflammatory condition caused by damage to the insulating covers of the nerves in the spinal cord and brain. The cause of MS is still unknown, but some symptoms of the disease include muscle weakness, problems with speech and swallowing, visual deficiencies, loss of sensitivity, and bladder and bowel irregularities.
The company would need another three years of complete studies to prove that Lemtrada is worth the risk to multiple scleroris patients.
Coincidentally enough, Lemtrada was approved this month in the European Union, Canada and Australia. Investors are looking forward to the profits that come from selling the multiple sclerosis drug. MS drugs and treatments are projected to make a whopping $20.2 billion a year by 2017.
Unfortunately there is not a known cure for MS. Treatments attempt to reduce the effect of an attack and help to prevent new symptoms from developing.
The future for Lemtrada in the United States remains bleak at this point.