PRAC Updates Restrictions on Alemtuzumab for MS

Megan Brooks


October 31, 2019

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has updated restrictions on the use of alemtuzumab (Lemtrada, Genzyme) for patients with relapsing-remitting multiple sclerosis (MS) to help minimize the risk for serious side effects.

At its October meeting, the committee advised that alemtuzumab only be used in adults who have highly active disease despite adequate treatment with at least one disease-modifying therapy or in cases in which the disease is worsening rapidly with at least two disabling relapses in 1 year and in which brain imaging shows new damage.

These updated recommendations replace temporary restrictions issued in April 2019 while the PRAC's review was underway.

Those temporary restrictions, as reported by Medscape Medical News, advised that treatment with alemtuzumab only be initiated in adults with relapsing-remitting MS that is highly active despite treatment with at least two other disease-modifying therapies or in those who can't take other disease-modifying therapies.

Also, the PRAC now recommends that alemtuzumab no longer be used in patients with certain heart, circulatory, or bleeding disorders or in patients who have autoimmune disorders other than MS.

Last year, the US Food and Drug Administration warned about the potential for "rare but serious" cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection associated with alemtuzumab therapy, as reported by Medscape Medical News.

In a statement issued today, the EMA said the new recommendations "reflect PRAC's review of reports concerning rare but serious effects, including deaths, from immune-mediated conditions and serious heart, circulation and bleeding disorders, including stroke. Immune-mediated conditions can occur many months after treatment while serious disorders of the heart, circulation and bleeding may develop within days of receiving Lemtrada."

The PRAC also recommended updating the physician's guide and the patient information pack with advice to minimize these risks.

The PRAC recommendations will now be sent to the EMA's Committee for Medicinal Products for Human Use, which will adopt the agency's final opinion.

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