Eli Lilly Says FDA Panel Supports Wider Use Of Antidepressant Drug Cymbalta - Update

Drug maker Eli Lilly and Co. (LLY) said Thursday that the Anesthetic and Life Support Drugs Advisory Committee of the Food and Drug Administration supported the use of the company's antidepressant drug Cymbalta to treat chronic low back pain. The company said that the committee expanded pain indications for the drug to a broader pain population, that will be further defined by the agency, if approved, and voted 8-6 in favor of increasing the drug's uses. If broader uses for the drug are approved, Eli Lilly could see an increase in sales. The patent for Cymbalta is valid until the middle of 2013.

According to the company, the panel reviewed efficacy and safety data from three new Cymbalta studies in chronic low back pain and two new studies in chronic pain due to osteoarthritis of the knee, along with overall safety data for the medication. The submission was also supported by currently approved indications in the management of diabetic peripheral neuropathic pain and fibromyalgia, which is pain in the muscles and connective tissues.

Cymbalta or duloxetine HCl is approved in the United States for the treatment of major depressive disorder, generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and fibromyalgia, in adults. The drug is not approved for use in pediatric patients.

Although the exact ways that the drug works in people is unknown, it is believed to be related to an increase in the activity of serotonin and norepinephrine, two naturally occurring substances in the brain and spinal cord, which are believed to mediate core mood symptoms and help regulate the perception of pain.

"Lilly is committed to helping people with unmet medical needs. 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 individualized," said Robert Baker, M.D., global development leader for psychiatry and pain disorders at Lilly. "We see today's vote as an important step in potentially making Cymbalta available to a broader pain population."

Eli Lilly said that while the submission was not designed to support individual indications, the committee was also asked to vote on the adequacy of evidence for efficacy in chronic low back pain and chronic pain due to osteoarthritis individually. In split votes the advisory committee was supportive of chronic low back pain based on two positive studies, but not chronic pain due to osteoarthritis based on a single positive study. It also voted that there was insufficient evidence of significant additional efficacy of 120 mg, compared with 60 mg in these conditions.

In addition, the committee's vote was positive regarding the overall safety profile of the therapy, including potential liver toxicity, with the majority agreeing that the benefit-risk profile warrants an expanded indication.

LLY closed Thursday's last trade at $34.28, down $0.50 or 1.44%, on a volume of 10.57 million shares on the NYSE. In the after hours the stock traded down $0.01 or 0.03%.

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