EMA starts review of Gilenya; guidance on biosimilar interferon beta

The European Medicines Agency has begun a review of the benefits and risks of Swiss drug major Novartis’ (NOVN: VX) multiple-sclerosis drug Gilenya (fingolimod). This follows concerns over the effects of the medicine on the heart after the first dose, the agency says. The news saw Novartis shares fall 5.5% to 55.11 Swiss francs in morning trading on Friday.

Gilenya was approved in Europe last spring for the treatment of relapsing-remitting multiple sclerosis in patients whose disease has failed to respond to a beta-interferon or is severe and getting worse rapidly, and in the USA the year earlier. It was hailed as a significant advance in MS treatment with a peak sales potential of $2 billion to $3.5 billion (The Pharma Letter March 21, 2011).

The review was started following reports of heart problems in patients taking Gilenya, as well as the death of one patient in the USA less than 24 hours after the first dose. The exact cause of this patient's death is still unexplained, said the EMA. In addition to the unexplained death in the USA, 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.