August 19, 2010 / 7:40 PM / 9 years ago

FDA panel backs wider use of Eli Lilly's Cymbalta

BETHESDA, Maryland (Reuters) - Eli Lilly and Co’s antidepressant Cymbalta should be approved to help ease chronic pain in certain patients, a U.S. medical advisory panel said on Thursday.

A U.S. Food and Drug Administration panel of outside advisers, in a series of votes, backed the drug’s wider use but split over whether it effectively treated lower-back pain and osteoarthritis. The panelists voted 8-5 to approve its use for back pain. But by a 4-9 vote they found there was not enough data to support its use to treat osteoarthritis.

“I think it will be a very useful drug for a significant number of patients,” the panel’s chairman Jeffrey Kirsch, head of anesthesiology at Oregon Health & Science University, said.

The drugmaker is seeking U.S. approval to more widely market Cymbalta, which is already cleared to treat depression, anxiety, diabetes-related pain and fibromyalgia.

If the drugmaker wins approval, it could see a temporary boost in sales ahead of generic competition against the antidepressant and several other key drugs in the next few years. Cymbalta loses its U.S. patent protection in mid-2013.

Analysts expect the anti-depressant to see $3.4 billion in worldwide sales in 2010 and $3.7 billion in 2011, according to consensus forecast data by Thomson Reuters, although it was unclear if potential approval was factored into the figures.

If the FDA does approve the pain use, Credit Suisse analysts said they expect it “to be somewhat limited and the incremental sales benefit to be modest,” according to their research note after the meeting.

While doctors are generally free to use approved medications for non-approved uses, so called “off-label use,” the FDA’s stamp of approval would allow Lilly to legally promote the new pain use.

The FDA will weigh its advisory panel’s recommendation before making its final approval decision. Lilly has said the deadline for the FDA to act has already passed, meaning a decision could come any time.

Lilly’s shares were down 1.5 percent, or 53 cents, to $34.25 in late afternoon trade, roughly in line with the overall market. Earlier on Thursday, a U.S. judge temporarily blocked a generic version of the drugmaker’s attention deficit disorder drug Strattera [nN16218165].


FDA officials said they were concerned about the impact of widening approval for a drug that has known serious side effects such as liver damage. Other risks with Cymbalta, also known as duloxetine and first approved in 2004, include suicidal thoughts and behaviors, nausea and drowsiness.

At the meeting, FDA data showed Cymbalta is already heavily used off-label for various conditions such as musculoskeletal conditions, headaches and nerve pain. Sales of the drug have grown three-fold to 14.7 million prescriptions in 2009, up from 5 million in 2005.

Eli Lilly told FDA’s panelists that Cymbalta offered another option for the more than 50 million Americans who suffer from chronic pain. No new safety problems have been found, and other painkillers such as opioids and nonsteroidal anti-inflammatory drugs also have risks such as abuse and heart problems.

“The efficacy of ... current therapies is very limited,” said Daniel Clauw, a University of Michigan professor who spoke on behalf of the drugmaker.

Panelists agreed to a certain extent and said Cymbalta would help give certain pain patients additional options.

Chronic, low-back pain in particular “doesn’t have many very effective treatments,” panel member Maria Suarez-Almazor, chief of rheumatology at the University of Texas MD Anderson Cancer Center said.

But panelists also said there was not enough data to support a stronger 120 milligram dose over the current 60 milligram version.

The drugmaker initially sought wider U.S. approval for pain in November 2008, but withdrew its bid to submit more data.

Reporting by Susan Heavey, editing by Leslie Gevirtz

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