Sanofi subsidiary Genzyme has received approval from Mexico’s national regulatory authority COFEPRIS for its Lemtrada (alemtuzumab) to treat patients with relapsing remitting forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.
Lemtrada is supported by a clinical development programme that included around 1,500 patients and 5,400 patient-years of follow-up.
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Approval is based on two randomised Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif) 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), as well as an ongoing extension study.
In CARE-MS I, Lemtrada was seen to be more effective than interferon beta-1a at reducing annualised relapse rates; the difference observed in slowing disability progression did not reach statistical significance.
The drug was more effective than interferon beta-1a at reducing annualised relapse rates, and accumulation of disability was slowed in patients given Lemtrada vs. interferon beta-1a.
Common side effects of Lemtrada are infusion associated reactions, infections, lymphopenia and leukopenia.
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By GlobalDataThe Mexican approval of Lemtrada follows the recent approvals of Lemtrada in Canada, Australia and the European Union (EU). Its marketing applications for Lemtrada are also under review in other countries.
However, the drug is not currently approved in the US and the company previously received a complete response letter from the FDA on its application for US approval of Lemtrada. The company plans to appeal the agency’s decision.
University of Guadalajara Department of Neuroscience professor Miguel Macias said: "The positive effect on disability progression demonstrated in clinical studies underscores Lemtrada’s ability to address the course of disease in a potentially transformative way for patients with relapsing remitting MS."
The company said that Lemtrada has also been granted orphan drug designation in Mexico.
More than 2.3 million people worldwide have been diagnosed with MS, including 15,000 people in Mexico.
Lemtrada 12mg has a new dosing and administration schedule of two annual treatment courses, the first course of the drug is administered via intravenous infusion on five consecutive days, and the second course is given on three consecutive days, 12 months later.
Genzyme president and CEO David Meeker said the approvals in the European Union, Australia, Canada and now Mexico demonstrated Lemtrada’s potential to have a positive impact on the lives of MS patients.
"Genzyme remains committed to providing new hope for the MS community and plans this year to launch Lemtrada in more than 30 countries, and hopefully additional markets where the treatment is still under review," Meeker said.
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells.
While Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialisation in multiple sclerosis, Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the US.
Image: Photomicrograph of a demyelinating MS-Lesion. Photo: courtesy of Marvin 101.
