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FDA advisors back expanded Cymbalta use

An FDA advisory committee has recommended the approval of new pain indications for Eli Lilly's Cymbalta (duloxetine)

An advisory committee to the US Food and Drug Administration (FDA) recommended after a close vote that the federal agency approve new pain indications for Eli Lilly's Cymbalta (duloxetine), the blockbuster drug that was originally approved six years ago as an antidepressant and a treatment for diabetic neuropathy pain. It was subsequently cleared for generalised anxiety disorder and fibromyalgia.

The Anaesthetic and Life Support Drugs Advisory Committee voted eight-to-six in favour of expanding the pain indications to a broader population after reviewing safety and efficacy data from studies testing the drug for chronic low back pain and for chronic pain due to osteoarthritis of the knee.

The committee was also asked by the FDA to make separate recommendations on the two uses. The panellists voted eight-to-five in favor of the lower back pain indication based on three studies submitted by Lilly. However, they voted nine-to-four that there was insufficient evidence to prove a benefit for osteoarthritis pain.

One of the studies Lilly submitted for that indication showed a reduction in pain, while the other did not achieve a statistically significant change.

The FDA is not required to follow the recommendations of its advisory committees, though it frequently does so.

"For people living with chronic low back pain and chronic pain due to osteoarthritis, we believe it's important they have different treatment options available since responses to medications can be highly individualised," Robert Baker, Lilly's global development leader for psychiatry and pain disorders, said in a statement.

Cymbalta brought in $3bn for Lilly last year, making it the second most profitable drug in the company's portfolio. Some financial analysts have pointed out that even if the FDA does approve the expanded uses of Cymbalta, the drug's sales may not increase by much, since it is already prescribed off-label to many patients for the unapproved indications. 

Cymbalta is also in late-stage clinical trials as a treatment for chronic fatigue syndrome.

In addition, it is approved for stress urinary incontinence in Europe, although the FDA declined to clear it for that use due to safety concerns.

23rd August 2010

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