Eli Lilly and Company Announces Approvable Letter Issued by FDA for Arxxant(TM) (ruboxistaurin mesylate)
August 18 2006 - 8:00AM
PR Newswire (US)
INDIANAPOLIS, Aug. 18 /PRNewswire-FirstCall/ -- Eli Lilly and
Company announced today that it received an approvable letter from
the U.S. Food and Drug Administration (FDA) for ruboxistaurin
mesylate (proposed trade name Arxxant(TM), pronounced, ark-ZONT),
its investigational oral therapy being studied for treatment of
diabetic retinopathy (DR), a diabetic eye disease. In its letter,
the FDA has requested submission of additional data to support the
clinical evidence presented by Lilly in its new drug application
(NDA). Lilly plans to meet with the FDA to determine whether this
request can be satisfied with data from an ongoing study or whether
a new study is required. "We will be working closely with the FDA
to address issues outlined in the approvable letter and to define
the pathway forward," said Dr. Timothy R. Franson, Vice President
of Global Regulatory Affairs, Eli Lilly and Company. About Arxxant
Arxxant is an investigational therapy for the treatment of moderate
to severe non-proliferative diabetic retinopathy. It works by
limiting the overactivation of protein kinase C beta (PKC b), a
naturally occurring enzyme that has been linked to the development
of diabetic retinopathy. It is the first of a new class of
compounds being investigated for the treatment of moderate to
severe non-proliferative diabetic retinopathy. Lilly submitted a
new drug application (NDA) to seek approval from the U.S. Food and
Drug Administration for ruboxistaurin for the treatment of moderate
to severe non-proliferative diabetic retinopathy in February 2006.
About Diabetic Retinopathy Diabetic retinopathy (DR) occurs when
diabetes damages the small blood vessels in the retina, a part of
the eye that is needed for vision. This damage can lead to vision
loss and possible blindness. DR affects an estimated 4.1 million
Americans age 40 and older with 899,000 having a vision-
threatening form of the disease,(1) and it is the leading cause of
blindness among working-age adults.(2) Lilly's Leadership in
Diabetes Through a long-standing commitment to diabetes care, Lilly
provides patients with breakthrough treatments that enable them to
live longer, healthier and fuller lives. Since 1923, Lilly has been
the industry leader in pioneering therapies to help health care
professionals improve the lives of people with diabetes, and
research continues on innovative medicines to address the unmet
needs of patients. About Lilly 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 the investigational compound
ruboxistaurin for the treatment of 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. There is also
no guarantee that the product will prove to be commercially
successful. 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 (1) Kempen, et al.: The
Prevalence of Diabetic Retinopathy Among Adults in the United
States. Arch Ophthalmol, 122:552-563 (2004). (2) Fong, et al.:
Retinopathy in Diabetes. Diabetes Care, 27:584-587 (2004) (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, +1-317-433-8990
(office), +1-317-532-7826 (mobile), Sharon Corbitt, +1-317-277-1574
(office), +1-317-997-1206 (mobile), both of Lilly
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