EMA to review safety of MS drug Gilenya
pharmafile | January 20, 2012 | News story | Research and Development, Sales and Marketing | CHMP, EMA, Novartis, gilenya
The European Medicines Agency has begun a review into the safety of Novartis’ multiple sclerosis drug Gilenya.
This follows concerns over the effects of the medicine on the heart after the first dose, according to the Agency.
The review was started following reports of heart problems in patients taking Gilenya (fingolimod), as well as the death of one patient in the US less than 24 hours after the first dose.
The exact cause of this patient’s death is still unexplained, but the FDA has also started a safety probe into the risk and benefits of the drug.
In addition to the unexplained death in the US, six other unexplained deaths (including three cases of sudden death) after starting treatment with Gilenya have also been reported.
Other reports include three deaths due to heart attack and one due to disruption of the heart rhythm. Currently, it is not clear if these were caused by Gilenya or not.
While the review is ongoing, the Agency’s Committee for Medicinal Products for Human Use (CHMP) is advising doctors to increase their level of monitoring of patients after the first dose of the medicine.
This includes electrocardiogram monitoring before treatment and then continuously for the first six hours after the first dose.
After six hours, any patients with clinically important heart-related effects, such as bradycardia (a slow heart rate), should continue to be managed and monitored until their condition improves.
The EMA said that the risk of bradycardia after the first dose of Gilenya was known when it was authorised.
The medicine’s product information already includes recommendations to observe patients for signs and symptoms related to this side effect, for at least six hours after the first dose.
Novartis said it will supply the CHMP with the results of its ongoing investigations into the cardiovascular effects of this medicine.
The CHMP expects to finalise its review by the time of its plenary meeting in March 2012.
Ben Adams
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