No Additional Studies Required Before Approval; Final Approval Contingent Upon Resolution of Manufacturing Issues and Completion of Label Negotations
The U.S. Food and Drug Administration issued a second approvable letter for Cymbalta™ (duloxetine HCl; pronounced SIM-BALL-TA), a potent serotonin and norepinephrine reuptake inhibitor, Eli Lilly and Company (NYSE: LLY) announced today. Approval is contingent upon resolution of manufacturing issues at Lilly's Indianapolis manufacturing facilities, including a pre-approval site inspection, and the completion of label negotiations.
"This second approvable letter is good news because it confirms that Cymbalta can be approved without any additional studies," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "The successful resolution of manufacturing issues in Indianapolis, and ultimately rebuilding world-class manufacturing and quality capabilities, remains one of Lilly's top priorities."
Lilly believes the FDA is in the final stages of its overall assessment of the company's manufacturing status. The company expects to have clarity on this matter prior to the end of this year. After Lilly resolves its manufacturing issues to the satisfaction of the agency and completes a successful pre-approval inspection, the company will update the approval and launch timing for Cymbalta.
Lilly received an approvable letter for Cymbalta in September 2002 noting satisfactory resolution of manufacturing issues and label negotiations as the contingencies for approval. On Sept. 3, 2003, Lilly also announced receipt of an approvable letter for another indication for the duloxetine molecule, stress urinary incontinence (SUI). Final approval for the SUI indication is contingent upon successful completion of additional acute pre-clinical and clinical pharmacology studies, satisfactory resolution of manufacturing issues and label negotiations.
About Depression and Cymbalta
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Despite advances, depression remains one of the most common and costly chronic illnesses. Nearly 19 million Americans suffer from depression each year, making it a leading cause of disability according to the World Health Organization. Studies show only one in three sufferers will ever achieve complete resolution of their symptoms. Research suggests an imbalance of two neurotransmitters play a key role, not only in the emotional symptoms of depression, but also in the painful physical symptoms commonly associated with depression. Data presented at the 2003 American Psychiatric Association annual meeting showed patients whose painful physical symptoms were relieved were more likely to achieve remission of their depression than those who did not receive relief of their painful physical symptoms.i
Cymbalta is believed to affect the levels of two key neurotransmitters involved in depression – serotonin and norepinephrine – both implicated in the complex spectrum of major depression symptoms. Prozac and many other common antidepressants, in contrast, affect only serotonin.
So far, more than 3,000 patients have taken Cymbalta in clinical trials. Data suggest Cymbalta 60 mg once daily relieves symptoms of depression, such as low mood, anxiety and physical symptoms like aches and pains, as measured by commonly used depression rating scale, the Hamilton Depression Rating Scale. The most commonly observed adverse events from Cymbalta were nausea, dry mouth, constipation, decreased appetite, fatigue, somnolence and increased sweating. The overall discontinuation rate due to adverse events for Cymbalta in all placebo-controlled trials was 10 percent vs. 4 percent for placebo.
Lilly signed a commercialization agreement for Cymbalta in the United States with Quintiles Transnational Corp. in July 2002.
About Eli Lilly and Company
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. Additional information about Lilly is available at www.lilly.com.
This news release contains forward-looking statements that reflect management's current beliefs about the potential for duloxetine in the treatment of depression. 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 filed August 2003. The company undertakes no duty to update forward-looking statements.
i. Poster presented at American Psychiatric Association annual meeting. May 19, 2003. San Francisco, Calif.