* Eli Lilly's Cymbalta OK'd for chronic pain -FDA panel
* Panelists split over back pain, arthritis use
* Drugmaker seeking FDA approval to promote new use
* FDA deadline passed, decision could come any time
* Shares down 1.5 percent amid broad stock drop
(Adds FDA meeting details, analyst's comment, byline)
By Susan Heavey
BETHESDA, Md., Aug 19 Eli Lilly and Co's
(LLY.N) 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].
CYMBALTA'S SIDE EFFECTS
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
"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
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)