Novartis/Mitsubishi Tanabe's Gilenia remains on track for blockbuster sales in the multiple sclerosis drug market

In the multiple sclerosis drug market, Novartis/Mitsubishi Tanabe Pharma's oral disease-modifying therapy Gilenia (fingolimod/FTY-720) remains on track to achieve blockbuster status by 2018, following a recent positive recommendation by a US Food and Drug Administration panel regarding the drug's  safety and efficacy in the treatment of relapsing forms of the disease (The Pharma Letter June 11).

According to Decision Resources' Pharmacor 2010 this development is in line with its previous forecast that Gilenia will attain regulatory approval for the treatment of multiple sclerosis in the USA, France, Germany, Italy, Spain, the UK and Japan. Following its expected approval for multiple sclerosis, Decision Resources forecasts that Gilenia will garner major-market peak-year sales in excess of $1 billion.

"The FDA advisory committee provided a strong show of confidence in Gilenia when it voted unanimously that the drug is safe and effective," said Decision Resources analyst Jonathan Searles. "It also voted against language recommending that Gilenia should only be prescribed after patients fail first-line therapies. This development is significant because many of the neurologists we interviewed perceive Gilenia largely as a second-line or later therapy, owing to certain safety risks associated with the drug," he noted.