The U.S. Food and Drug administration (FDA) has given the green signal to biotech company Genzyme's drug for multiple sclerosis (MS) Lemtrada.
The FDA issued the approval for Lemtrada's sale in the U.S. on Saturday, Nov. 15. Lemtrada can now be used in the treatment of individuals who suffer from relapsing forms of MS. The drug, however, will come with a boxed warning.
The ruling comes 11 months after the drug's sale was initially rejected by the FDA, citing severe side effect concerns. However, the regulators reversed the ruling and gave the go-ahead to Lemtrada after Genzyme re-appealed and submitted an analysis highlighting the drug's benefits vis-à-vis risks to quash FDA's concerns on safety.
"Today's approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada," said [PDF] David Meeker, Genzyme President and CEO.
Lemtrada is already approved in over 40 countries, including Canada, some EU nations, South Korea and Australia. Nearly 400,000 people in America are believed to be affected by MS, which affects an individual's nervous system and brain.
Lemtrada is administered in a unique manner i.e. two annual treatment course methods. The first treatment method is via an intravenous infusion for five successive days. The second treatment course requires administration for three successive days after a year.
Side effects of the drug include nausea, rashes, headaches, diarrhea, stomach pain, sinusitis, insomnia, tiredness, dizziness, flushing, fungal infections, vomiting and more.
To ensure safety, Lemtrada will come with a boxed warning that highlights the risk of infusion reactions that may be life-threatening and fatal. The drug is also capable of increasing the risk of melanoma, thyroid cancer and other malignancies.
Moreover, Lemtrada will be sold only via the risk evaluation and mitigation strategy (REMS) program in the U.S., ensuring that only certified pharmacies and healthcare facilities can retail the drug.
"We are pleased that the voices of the MS community have been recognized and that people with relapsing MS will now have access to a new, needed treatment option," said Dr. Timothy Coetzee, of the National MS Society.
