Sanofi subsidiary Genzyme has received approval from the Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) for its Lemtrada (alemtuzumab) for treatment of multiple sclerosis.
ANMAT has approved Lemtrada, a monoclonal antibody that selectively targets CD52, for treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Genzyme president and CEO David Meeker said: "We are launching the treatment in more than 30 countries this year, and look forward to additional approvals where Lemtrada is still under review."
Lemtrada is supported by a clinical development programme that involved nearly 1,500 patients and 5,400 patient-years of follow-up.
The clinical development programme included two 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 has demonstrated more effectiveness than interferon beta-1a in reducing annualised relapse rates.
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In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualised relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada compared to interferon beta-1a.
Lemtrada is already approved in the EU, Australia, Canada, Mexico, Brazil, and Guatemala, and is currently not approved in the US.
Genzyme has the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialisation in multiple sclerosis. Bayer HealthCare has the right to co-promote alemtuzumab in multiple sclerosis in the US.
Image: Chemical structure of alemtuzumab. Photo: courtesy of Fvasconcellos.