FDA OKs Genzymes injectable MS drug it rejected last year

Federal regulators have approved an injectable multiple sclerosis drug developed by Cambridge biotech Genzyme 10 months after it was initially rejected.

Genzyme announced the approval of Lemtrada, a medication to treat patients with relapsing forms of the debilitating disease, last night.

Todays approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada, Genzyme President and CEO David Meeker said in a statement. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.

Lemtrada, which is already sold in Europe, was rejected by the FDA last December after medical experts raised concerns about its safety and the quality of clinical studies.

Two new studies comparing Lemtrada to EMD Seronos drug Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy prompted the FDAs course reversal after Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates, Meeker said.

Multiple sclerosis is a chronic, autoimmune condition that affects more than 2 million people worldwide and up to 400,000 in the United States.

The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS in the United States, said Dr. Timothy Coetzee of the National MS Society. 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.

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FDA OKs Genzymes injectable MS drug it rejected last year