Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia
Published: May 29, 2008
COLLEGEVILLE, Pa., May 29 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the first-in-class antibiotic TYGACIL(R) (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP).
Before granting approval, the FDA requested that Wyeth provide additional analyses to support the safety and efficacy of TYGACIL for the treatment of patients with CAP with illness severe enough to require hospitalization, including those who are at higher risk of mortality.
In addition, the FDA requested information regarding the benefit/risk of TYGACIL for any potential of liver toxicity. Wyeth recently provided that information to the agency during the review period and believes that its response adequately addresses the issues raised by the FDA. However, the agency acknowledged in its letter that it had not yet reviewed that information.
"We believe the data from our current clinical development program support TYGACIL as a potential therapeutic option for patients with CAP," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "Wyeth is committed to working with the FDA to resolve the outstanding issues for TYGACIL in order to gain approval."
TYGACIL was approved by the FDA in June 2005 for the treatment of adult patients with complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI).
Wyeth has achieved significant success in bringing new products to market. Year to date, the Company has obtained three new product approvals in the following therapeutic areas: major depressive disorder, Hemophilia A and opioid-induced constipation.
About Community-Acquired Pneumonia
CAP is defined as pneumonia acquired outside a hospital or long-term care facility. It is an infection of the lungs that results in decreased ability to function normally. Although pneumonia is not a reportable illness, it appears that up to 5.6 million cases of community-acquired pneumonia occur annually. In addition, hospitalization rates among patients with CAP are approximately 20 percent. Symptoms of CAP include cough, fever, chills, fatigue, shortness of breath, and chest pain.
About the CAP Clinical Trials
TYGACIL was evaluated in adults for the treatment of CAP in two phase 3, multicenter, randomized, double-blind studies. The two studies (N=418, N=434) were conducted at 116 sites in 28 countries across the globe and evaluated the efficacy and safety of tigecycline compared with levofloxacin in subjects hospitalized with CAP.
TYGACIL is indicated for the treatment of adults with:
Complicated skin and skin structure infections (cSSSI) caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and Bacteroides fragilis.
Complicated intra-abdominal infections (cIAI) caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.
TYGACIL can be used as an empiric monotherapy to treat a variety of cIAI and cSSSI, both hospital- and community-acquired, including complicated appendicitis, intra-abdominal abscesses, infected burns, deep soft-tissue infections, and infected ulcers.
TYGACIL, a first-in-class glycylcycline, is an IV antibiotic with an expanded broad spectrum of in vitro activity against gram positives, gram negatives, anaerobes, methicillin-resistant and -susceptible Staphylococcus aureus (MRSA and MSSA) and vancomycin-resistant enterococci (VRE); TYGACIL is unaffected by extended-spectrum beta-lactamases (ESBLs).
In addition, TYGACIL has been shown to have in vitro activity against the following organisms: Enterococcus avium, Enterococcus casseliflavus, Enterococcus faecalis (vancomycin-resistant isolates), Enterococcus faecium (vancomycin-susceptible and -resistant isolates), Enterococcus gallinarum, Listeria monocytogenes, Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates), Acinetobacter baumannii, Aeromonas hydrophila, Citrobacter koseri, Enterobacter aerogenes, and Pasteurella multocida. The clinical significance of in vitro activity is unknown.
TYGACIL provides clinicians with an expanded broad-spectrum antibiotic option that can be used at the onset of treatment when the specific bacteria present are not yet known. In addition, TYGACIL does not require dosage adjustment in patients with impaired renal function, and is conveniently dosed every 12 hours.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, there can be no assurance that our pending supplemental new drug application for TYGACIL for the CAP indication will be approved or that the product will ever be successfully commercialized for CAP or other indications. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward-looking statements include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. The forward-looking statements in this press release are qualified by these risk factors.
We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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