FDA Approved "Gilenya"

We have a winner in the U.S. race to market a pill for multiple sclerosis — Novartis!
The FDA said today it approved the Swiss drug maker’s Gilenya (known generically as fingolimod) for use against the most common type of MS.
Here’s the WSJ story on the agency’s decision. An FDA advisory committee voted unanimously in June to recommend the drug for approval.
Merck KGaA is awaiting an FDA decision on its own MS pill, cladribine. And Biogen Idec has a pill, BG-12, in late-stage trials. Biogen shares slid today on fears Gilenya will compete with its existing MS therapies Avonex and Tysabri.
Forbes’ The Medicine Show blog notes the surprise weighing on Biogen shares was the relative lack of restrictions the FDA placed on Gilenya. The drug carries the small risk of side effects (including herpes infections and some forms of cancer) and Novartis agreed to monitor patients for side effects as a condition of approval — but not as extensively as expected. Biogen issued its own press release today emphasizing its MS portfolio and pipeline and emphasizing the need for companies bringing these drugs to market to “be rigorous in monitoring” for safety problems.
Ah, you may ask — but how much will it cost? Novartis won’t put a dollar figure on Gilenya, reports NPR’s Shots Blog, but analysts put the annual price tag at $30,000 to $35,000 a year, in the same neighborhood as the currently available injectable drugs. Clinical trials showed Gilenya cut the risk of attacks compared to Avonex (an injectable) and a placebo.

We have a winner in the U.S. race to market a pill for multiple sclerosis — Novartis!
The FDA said today it approved the Swiss drug maker’s Gilenya (known generically as fingolimod) for use against the most common type of MS.
Here’s the WSJ story on the agency’s decision. An FDA advisory committee voted unanimously in June to recommend the drug for approval.
Merck KGaA is awaiting an FDA decision on its own MS pill, cladribine. And Biogen Idec has a pill, BG-12, in late-stage trials. Biogen shares slid today on fears Gilenya will compete with its existing MS therapies Avonex and Tysabri.
Forbes’ The Medicine Show blog notes the surprise weighing on Biogen shares was the relative lack of restrictions the FDA placed on Gilenya. The drug carries the small risk of side effects (including herpes infections and some forms of cancer) and Novartis agreed to monitor patients for side effects as a condition of approval — but not as extensively as expected. Biogen issued its own press release today emphasizing its MS portfolio and pipeline and emphasizing the need for companies bringing these drugs to market to “be rigorous in monitoring” for safety problems.
Ah, you may ask — but how much will it cost? Novartis won’t put a dollar figure on Gilenya, reports NPR’s Shots Blog, but analysts put the annual price tag at $30,000 to $35,000 a year, in the same neighborhood as the currently available injectable drugs. Clinical trials showed Gilenya cut the risk of attacks compared to Avonex (an injectable) and a placebo.

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