Novartis' ($NVS) multiple sclerosis treatment Gilenya dodged a bullet in the EU when the European Medicines Agency (EMA) said it could remain on the market but needed stronger warnings and an EKG. The company said it also agreed to an FDA request for similar language on labels in the U.S.
Analysts will give a big sigh of relief given that predictions for the drug are that it could generate blockbuster-sized returns. It was particularly gratifying given that just a week ago, the Swiss company acknowledged that a patient had developed a sometimes fatal brain disease after starting the drug. The company points out that the patient had previously been treated with Tysabri, a multiple-sclerosis treatment from Biogen Idec ($BIIB) and Elan ($ELN), which has already been tied to the sometimes-fatal brain disease known as PML.
Gilenya is the only oral treatment for MS, and predictions at one point were that the treatment would rake in $2.2 billion a year, reminds Reuters. That was trimmed to $1.7 billion a year by 2015 after reports of heart issues arose, including one of a patient in the U.S. dying of heart problems within 24 hours of starting the treatment.
That is presumably why the EMA says Gilenya can should generally not be given to patients receiving heart-rate lowering medication or who have suffered from any cardiovascular and cerebrovascular disease. If a doctor feels Gilenya is required in one of those patients, the EMA says the patient must be monitored at least overnight after the first dose. It said anyone getting the MS treatment needs to have an electrocardiogram (ECG) and a blood pressure measurement prior to the first dose and after a 6-hour initial period, during which continuous ECG monitoring is recommended.
NICE, the regulatory agency in the U.K., has already given an approval to the treatment.