Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Re
29 September 2006 - 11:30PM
PR Newswire (US)
Additional Trial Would Take Up To Five Years to Complete; Lilly
Currently Evaluating Options INDIANAPOLIS, Sept. 29
/PRNewswire-FirstCall/ -- Eli Lilly and Company today announced
that it is weighing options for the further development of
ruboxistaurin mesylate in light of a request by the Food and Drug
Administration (FDA) for an additional, three-year, Phase 3
clinical trial. The FDA said it wants additional efficacy data
before it will consider approving the molecule for the treatment of
moderate to severe nonproliferative diabetic retinopathy. Lilly
believes that such a trial would require up to five years to
complete. Today's announcement follows Lilly's August 18, 2006,
announcement that it had received an approvable letter from the
FDA. "We are certainly disappointed with this communication from
the FDA. Diabetic retinopathy is a significant unmet medical need
to which we have devoted more than a decade of clinical research
with no guarantee of approval," said Dr. John Lechleiter, president
and chief operating officer of Eli Lilly and Company. "We still
believe that ruboxistaurin has potential as a treatment for
diabetic eye disease and are exploring the feasibility of further
development of this molecule," he added. Ongoing clinical trials
for ruboxistaurin will continue while Lilly evaluates its options
for further development of ruboxistaurin. Ruboxistaurin (proposed
brand name Arxxant(TM), pronounced ark-ZONT) was submitted to the
FDA in February 2006 and subsequently was granted priority review.
The August 17 approvable letter from the FDA requested additional
efficacy data to support the clinical evidence presented by Lilly
in its New Drug Application (NDA). Today's announcement results
from ongoing communication between Lilly and the FDA to determine
if the additional evidence could come from ongoing trials or if a
new trial would be required. At this time, Lilly does not intend to
withdraw the NDA, because withdrawal would require restarting the
review process, should Lilly ultimately move forward with
development of ruboxistaurin. Lilly, a leading innovation-driven
corporation, is developing a growing portfolio of first-in-class
and best-in-class pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Ind., Lilly provides answers -- through medicines
and information -- for some of the world's most urgent medical
needs. Additional information about Lilly is available at
http://www.lilly.com/. This press release contains forward-looking
statements about the potential of ruboxistaurin, an investigational
compound for the treatment of moderate to severe nonproliferative
diabetic retinopathy and reflects Lilly's current beliefs. However,
as with any pharmaceutical product under development, there are
substantial risks and uncertainties in the process of development
and regulatory review. There is no guarantee that the product will
receive regulatory approvals, or that the regulatory approval will
be for the indication(s) anticipated by the company. For further
discussion of these and other risks and uncertainties, see Lilly's
filings with the United States Securities and Exchange Commission.
Lilly undertakes no duty to update forward-looking statements.
P-LLY (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Marni Lemons, Lilly, +1-317-433-8990
(office), +1-317-532-7826 (mobile), Sharon Corbitt, Lilly,
+1-317-277-1574 (office), +1-317-997-1206 (mobile)
Copyright