Europe's drug regulator fears that Novartis MS Drug is being prescribed to patients with misleading safety warnings and this could terribly affect the people health in the region.
On Friday, the drug regulator has requested the concerned authorities to issue stronger safety warnings for Novartis AG's (NVS) Gilenya, as a review has confirmed that the multiple-sclerosis pill carries risks of suffering heart problems and can even lead to the death of a patient if he takes the drug.
The decision has recently come from London-based European Medicines Agency, the body that was responsible for licensing the pill in Europe a year ago.
In its statement, the company clearly lifted all the uncertainties that could happen from Gilenya, which Novartis earlier touted as a potential blockbuster.
But EMA is now efficiently supporting its existing warnings regarding the drugs and is strongly emphasizing that the authorities must immediately strengthen the existing warnings regarding the drug.
Also, the authority has urged that doctors must not prescribe Gilenya to patients, who have history of heart problems. Or if important, the drug must be prescribed only after thorough examination of heart and its regular monitor after every six hours after introducing the first dose to the patient.
"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", said Dr. David Epstein, Head of Pharmaceuticals at Novartis.
Officials insist similar warnings to be issued for Novartis package that are being sold in the U. S. also. Despite evidences of risks, Swiss drug maker still hopes that the drug’s easy use will lead treatments for MS in the multibillion-dollar market.
Reports are confirming that Gilenya last year generated sales of $494 million from the medical industry.