Last year, Food and Drug Administration denied the approval of Lemtrada due its inadequate clinical trials.
For this year's approval, the drug is cleared for patients with multiple sclerosis defined by periods of relapse and remission.
Lemtrada was approved last year in Europe. It was part of the $20.1 billion acquisition of Genzyme Corp in 2011. Lemtrada is an injectable. The Food and Drug Administration also approved tw other MS treatments in the US, making Sanofi a franchise of MS drugs.
Lemtrada is reserved for patients who have not received full benefit from the other two MS treatments. It is also available under restricted distribution because of potential risks such as fatal autoimmune conditions and malignancies. The drug can also cause thyroid cancer, the Sanofi statement said.
Multiple sclerosis is a $16 billion market and among the companies that sell MS treatment are Biogen Idec Inc (Avonex) and Teva Pharmceutical Industried Ltd (Copaxone). According to the National Institute of Neurological Disorders and Stroke, MS or multiple sclerosis is a neurological disease causing severe disability. It affects as many as 350,000 Americans and is more common in women.
During clinical trial of Lemtrada, patients who received five infusions on the first year followed by two to three the following year only spent $158,000 for the two to three years of treatment. Compared to Merck KGaA's Rebif's $135,000 per year treatment, Lemtrada is more cost effective treatment according to Sibold.
David Meeker, Genzyme's president and chief executive officer, said in a statement that, 'the approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada.'
