The recommendations reflect PRAC's review of reports concerning rare but serious effects, including deaths, from immune-mediated conditions (caused by the body's defence system not working properly) 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 has recommended restricting Lemtrada for use in adults with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage. Also, Lemtrada must no longer be used in patients with certain heart, circulation or bleeding disorders or in patients who have auto-immune disorders other than multiple sclerosis.
New measures have been recommended for identifying and promptly dealing with adverse effects that might occur after treatment with Lemtrada. It should be given in a hospital with ready access to intensive care facilities and specialists who can manage serious adverse reactions.
The PRAC has also recommended updating the physician's guide and the patient information pack with advice to minimise the risk of serious heart, circulation and bleeding disorders that may occur shortly after the infusion (drip) as well as autoimmune conditions that could occur many months after the last Lemtrada treatment.
The new recommendations replace the temporary measures issued in April 2019 while the PRAC's review was under way.
The PRAC recommendations will now be sent to EMA's human medicines committee (CHMP), which will adopt the Agency's final opinion.