Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, 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 U.S. Food and Drug Administration (FDA) panel regarding Gilenia's safety and efficacy in the treatment of relapsing forms of the disease.
The Pharmacor 2010 findings from the topic entitled Multiple Sclerosis reveal that this development is in line with Decision Resources' previous forecast that Gilenia will attain regulatory approval for the treatment of multiple sclerosis in the United States, France, Germany, Italy, Spain, the United Kingdom 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."
The Pharmacor 2010 findings also reveal that the launch of several additional high-priced oral disease-modifying therapies and the increasing use of current and emerging monoclonal antibodies will drive modest 3 percent annual growth in the multiple sclerosis market from 2008 to 2018. However, despite improvements offered by emerging agents, significant unmet need remains for therapies that halt or reverse disease progression and/or drugs that possess a better balance of efficacy, safety and convenience.
About Pharmacor 2010
The newly redesigned Pharmacor advisory service offers clients in the biopharmaceutical industry the most up-to-date information available on commercially significant disease topics.
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