FDA OKs Lilly Drug for Diabetes Pain

Eli Lilly & Co., which introduced the world’s first commercial insulin for diabetes in the 1920s, said Tuesday that U.S. regulators cleared its Cymbalta antidepressant for use in relieving diabetes-related nerve pain.

The Food and Drug Administration decision makes Cymbalta the first drug approved for diabetic peripheral neuropathic pain, a condition that the company estimates affects as many as 5 million Americans. Diabetes can damage nerves over time, leading to numbness or pain in hands, arms, feet and legs, according to the National Institutes of Health.

“The good news here is that this is a primary indication for pain,” said Martin J. Abrahamson, acting chief medical officer of the Joslin Clinic in Boston, which is affiliated with Harvard Medical School. Cymbalta “has been shown to relieve pain in controlled trials.”

The FDA approved Cymbalta last month for use as an antidepressant, and the additional clearance may increase annual sales to $5 billion, said Al Rauch, an analyst with A.G. Edwards & Sons Inc. He said Indianapolis-based Lilly’s product has a lead over Lyrica, which New York-based Pfizer Inc. is seeking clearance to sell as a treatment for pain and seizures. At least half of the 18 million diabetics in the U.S. may have some nerve damage, the NIH’s website said.

Lilly shares rose $1.02 to $66 on the New York Stock Exchange.

Cymbalta targets two chemical messengers in the brain, only one of which is targeted by Lilly’s older antidepressant Prozac. Cymbalta is Lilly’s first new antidepressant since the introduction of Prozac in the late 1980s.