After coming across few death cases due to Novartis AG's multiple-sclerosis drug Gilenya, the European Medical Agency (EMA) has started an investigation which would see its pros and cons. The EMA said that the main reason to conduct the review is to make sure that the drug is safe.
It is very important for Gilenya to get through this investigation process as fast as possible as it is the only drug meant for multiple sclerosis patients which can be taken in the form of pill. Other drugs that are available in the market are either taken through injection or after infusing it with other substance.
This was one of the qualities which led the U. S. Food and Drug Administration to give green signal to the drug in 2010 to be sold in the US market. Gilenya is also available in the European Union since March 2011. Its main use is to treat patients which have failed to respond beta-interferon.
The news has led the company’s share to fall by 5.5% on the New York Stock Exchange. The future of Gilenya is now dependant on the inquiry of the EMA, but the company officials are not worried about the outcome as they know they trust the efficacy of their drug.
However, industry experts said that Gilenya is the biggest bet of the Novartis and seems to be one of the most promising drugs in the medical market which cost about multi-billion. The EMA said that they have also asked doctors to monitor the health of patients after they take the first dosage of Gilenya.
Novartis said, “Individual reports of cardiovascular and sudden unexplained deaths must be put into the context of the background rate of these incidents in the general population”. The EMA has given no official date for the report, but has said that till now they have found Gilenya under the limits of permissible medical complication rate.












