Source:
Doctor's Guide
FDA Issues Approvable Letter for Strattera for ADHD
Strattera Would Give Patients, Families and Physicians a New Treatment
Option
INDIANAPOLIS, IN -- August 14, 2002 -- Eli Lilly and Company (NYSE:LLY) has
received an approvable letter from the U.S. Food and Drug Administration (FDA)
for Strattera(TM) (atomoxetine hydrochloride), a treatment for
Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and
adults.
Approval is contingent upon labeling discussions, and submission of additional
data or analyses from either existing studies or a potential new study. While
Lilly continues to plan for final FDA approval in the spring of 2003, approval
timing is contingent upon further discussions with the FDA regarding the
additional data requested.
"We are delighted to reach this important milestone in the development of
Strattera, and we are working closely with the FDA to complete this process as
quickly as possible," said John Lechleiter, executive vice president of
pharmaceutical products and corporate development at Eli Lilly and Company.
"We're eager to bring this new treatment option to patients, families and health
care professionals."
Lilly submitted its New Drug Application (NDA) for Strattera in October 2001. It
included data from six placebo-controlled studies, involving children,
adolescents and adults. So far, more than 4,000 patients have taken Strattera in
clinical trials.
ADHD affects 3-7 percent of school age children(1) and manifests itself in
levels of attention, concentration, activity, distractibility, and impulsivity
that are inappropriate to the child's age group.(2) Experts estimate 60 percent
of children with the disorder carry their symptoms into adulthood.(3)
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of 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.
This news release contains forward-looking statements that reflect management's
current beliefs about the potential for atomoxetine in the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD). However, as with any
pharmaceutical under development, there are significant risks and uncertainties
in the process of development and regulatory review. There are no guarantees
that the product will receive regulatory approvals or prove to be commercially
successful. There is also no assurance of the timing of final FDA action on the
compound. For additional information about the factors that affect the company's
business, please see Exhibit 99 to the company's latest Form 10-Q. The company
undertakes no duty to update forward-looking statements.
(1) American Academy of Pediatrics. Clinical practice guidelines: diagnosis and
evaluation of the child with attention-deficit/hyperactivity disorder.
Pediatrics. 2000; 105:1158-1170.
(2) American Psychiatric Association: Diagnostic and Statistical Manual of
Mental Disorders, fourth edition. Washington, DC, American Psychiatric
Association, 1994.
(3) American Psychiatric Association: DSM-IV-TR.2000.85-93 Schweitzer JB, et al.
Attention-deficit/hyperactivity disorder. Med Clin of North Am. 2001;
85(3):757-777.
Contact:
Eli Lilly and Company
David Shaffer, 317/651-3710
SOURCE: Eli Lilly and Company
