Multiple Sclerosis Pill Gilenya To Get New Safety Warnings In EU, U.S.

Multiple Sclerosis Pill Gilenya, made by Novartis, continues to receive backing by European and U.S. officials, despite a patient who recently developed a rare fatal brain disease after taking the pill, as well as reports of patients contracting heart problems.

European Medicines Agency made the decision last year to license the pill in Europe, and worked together with the company to assure patients that the drug is safe, and okay for use. Their review concluded this week with an agreement for Novartis to use a stronger warning label on it’s product.

A separate investigation done by U.S. Food and Drug Administration concluded the same way. The EMA also noted that, along with the strengthened warnings, doctors should not prescribe the pill to patients who have pre-existing heart problems.

The EMA said in a statement that, “With these risk-minimization measures in place, the committee concludes that the benefits of Gilenya continue to outweigh the risks.”

Gilenya is the first pill to treat Multiple Sclerosis, and has been proven through studies to slow down or even stop the progression of the disease in patients.

David Epstein, the Head of Pharmaceuticals at Novartis, stated that:

“We believe that Gilenya is a valuable treatment option for many patients with relapsing remitting MS, and we welcome the confirmation of the positive benefit-risk profile of the drug, which also supports our continued belief of the blockbuster potential of Gilenya.”

Nicholas Turner, an analyst for Mirabaud Securities also commented on the updated labels. He said during a telephone interview that:

“It’s certainly not any restriction of the label…my reading of it is that the EMA are endorsing the safety of Gilenya. It’s not bad news for the medicine. If anything it’s the opposite.”

Novartis reports that over 36,000 patients have taken the Multiple Sclerosis pill worldwide, and they anticipate the pill to be a “blockbuster,” as it has annual sales of over $1 million to date.

Check out the video below for more information about the Multiple Sclerosis pill Gilenya: