MS Genzyme Drug Lemtrada Approved in Argentina, Still Under Review in US

Lemtrada, a drug produced by Genzyme for the treatment of adult patients suffering from relapsing remitting multiple sclerosis (RRMS) with active disease, was approved by Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT).

“We are pleased by the continued global support for Lemtrada,” said Genzyme President and CEO, David Meeker. “We are launching the treatment in more than 30 countries this year, and look forward to additional approvals where Lemtrada is still under review,” as is still the case in the United States.

The development program of the drug was performed with two randomized Phase III studies. Scientists compared the Lemtrada treatment with high-dose subcutaneous interferon beta-1a in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).

However, while the first group demonstrated the significant effectiveness of the drug in reducing annualized relapse rates, the difference observed in slowing disability progression did not reach statistical significance. While in the second group, the difference between Lemtrada and subcutaneous interferon beta-1a was larger, confirming the effectiveness of Lemtrada in reducing annualized relapse rates and accumulation of disability.

“The Lemtrada clinical trial data demonstrating the treatment’s positive impact on relapse rates and disability progression support its potential as a transformational new treatment for relapsing-remitting multiple sclerosis,” said Norma Deri, M.D., Hospital Fernandez, Buenos Aires, Argentina. “The approval of Lemtrada is good news for people living with active MS, who are in need of additional treatment options that may offer greater efficacy.”

Of the 2.3 million people in the world diagnosed with MS, 8,000 live in Argentina. Besides Argentina, the drug has been approved in the European Union. The U.S. Food and Drug Administration has agreed to review the Genzyme resubmission of the application seeking approval of Lemtrada. The company expects a result in the fourth quarter of the year.

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Lemtrada (alemtuzumab) 12 mg works in two phases with a dosing and administration schedule. The first annual treatment course is administered via intravenous infusion on five consecutive days, while the second is administered on three consecutive days, 12 months later. However, the treatment involves some side effects, as infusion associated reactions, infections, lymphopenia, autoimmune conditions or serious infections, are all reasons why is so important to have a comprehensive risk management program incorporating education and monitoring.