US health regulator Food and Drug administration (FDA) on Saturday approved sale of the multiple sclerosis (MS) curing drug Lemtrada, manufactured by biotech company Genzyme, in the country.
The FDA decision arrives 11 months after the health body had initially rejected the sale of the drug on several side effect concerns.
Recently, Genzyme had filed a re-appeal with the FDA and submitted an analysis report to underline the benefits of the drug in treating the severe health condition. The regulatory body revoked its previous decision after the company’s report quashed all the safety concerns for the drug.
Now, Lemtrada can be used to effectively treat the patients suffering from relapsing forms of multiple sclerosis. It can prove to be beneficial for nearly 400,000 Americans who are believed to be affected by MS.
Welcoming the FDA decision [PDF] David Meeker, Genzyme President and chief executive, said, “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada.”
But the health officials said that the drug will come with a boxed warning to ensure safety against the life threatening risks of infusion reactions among the high risk group. Some of the other drawbacks of the drug are that it is also capable of raising the risk of thyroid cancer, skin cancer type ‘melanoma’, and other malignancies.
Multiple sclerosis (MS) is a health condition in which the nervous system and brain of the patient are affected.
Lemtrada is sold in over 40 countries, including Australia, Canada, European nations and South Korea.
Some of the side effects of the drug include skin rashes, headaches, nausea, stomach pain, diarrhea, sinusitis, insomnia, flushing, tiredness, dizziness, vomiting fungal infections and several others.