Lemtrada For RRMS Still Under Review in the U.S., Now Approved in Scotland

The Scottish Medicines Consortium (SMC)  announced the approval of the drug Lemtrada, produced by Genzyme, for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) and active disease defined by clinical or imaging features, within the national health system (NHS) in Scotland.

Lemtrada (alemtuzumab), a humanised monoclonal antibody therapy, has been proven effective in the depletion of circulating T and B cells, which are responsible for the damaging inflammatory process in MS. Reducing the levels of circulation of T and B cells using the medication is believed to reduce the potential for relapse, as well as the disease progression.

“Scotland has one of the highest rates of multiple sclerosis in the world, and the approval of Lemtrada in Scotland is an important step forward for people with active RRMS who remain in need of new treatment options,” said Dr. Belinda Weller, Consultant Neurologist, Western General Hospital, Edinburgh. “MS treatments have come a long way in the past twenty years and the availability of Lemtrada provides an opportunity for neurologists to offer a new therapy to people with multiple sclerosis.”

Throughout the course of numerous clinical trials conducted over the past ten years, Genzyme has verified that patients treated with Lemtrada reduced annualized relapse rates compared to patients treated with subcutaneous beta-interferon injected three times per week. Patients also revealed less possibilities of experiencing disability. As a result of research developed in collaboration with the University of Cambridge, more than 1,500 patients were administrated the drug in two short treatment courses. The first course included one infusion per day for five days and, one year later, the second course included one infusion per day for three days.

“RRMS accounts for eighty-five percent of all initial diagnoses in MS. We are pleased that after many years in development, Lemtrada is now available to patients in Scotland. This provides people with MS with an important and innovative treatment option to consider in partnership with their MS specialists,“ said Amy Bowen, Director of Service Development at the MS Trust.

This is second therapy from Genzyme to receive approval from the SMC and to be made available in Scotland. The drug has already been approved for NHS patients both in England and Wales, after having been approved by the National Institute for Health and Care Excellence (NICE).

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“We are thrilled by today‘s news that the SMC has approved Lemtrada for NHS use for people with RRMS. At Genzyme, patients at the heart of everything we do and this final milestone brings a treatment option to people with MS that could really reshape the management of their condition,” stated the General Manager for Genzyme UK and Ireland, Brendan Martin.

“We are also immensely proud of our association with Lemtrada as a home-grown product, developed and pioneered in Cambridge by a team of UK scientists. This reminds us of the UK‘s position at the forefront of science-led medicine, the importance of industry collaboration which brings global expertise in clinical development and our joint commitment to MS patients,” he added.

The drug, which is still under review in the United States, was recently approved in Argentina as well, by the National Administration of Drugs, Food and Medical Techology (ANMAT).