Healthcare Industry News: Prothrombin Time
News Release - October 24, 2007
FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired PneumoniaCOLLEGEVILLE, Pa., Oct. 24 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's supplemental New Drug Application (sNDA) for its first-in-class antibiotic TygacilŪ (tigecycline) for the treatment of patients with community-acquired pneumonia (CAP). The FDA now will complete its review of the application. The FDA may approve or disapprove the application, request additional data or take other administrative actions.
"CAP is a serious respiratory disease that affects millions of Americans," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "The acceptance of this sNDA is an important event as it brings Wyeth closer to providing physicians with a new option for the treatment of CAP."
The sNDA submission included integrated data from two investigational clinical studies that included 846 patients. Study data showed that Tygacil cured 89.7 percent of patients hospitalized with CAP, and levofloxacin - an existing treatment option for CAP - cured 86.3 percent of studied patients. The most common adverse events for Tygacil were nausea (24.3 percent), vomiting (16.0 percent) and abdominal pain (5.7 percent). The discontinuation rates due to adverse events for Tygacil and levofloxacin were similar (6.1 percent and 8.3 percent, respectively).
"As antibiotic resistance continues to be a concern for many strains of the most common bacteria causing CAP, there is a growing need for new options," says Thomas File, M.D., Chief of Infectious Disease Services for Summa Health System in Akron, Ohio.
About Community-Acquired Pneumonia
CAP is defined as pneumonia not acquired in a hospital or long-term care facility. It is a bacterial infection in the lung and is a common, but serious, respiratory disease affecting approximately 5.6 million Americans each year. The cost of treating patients with CAP is about $10 billion per year, with inpatient costs representing 92 percent of the total sum and hospitalized patients accruing nearly $7,500 each. CAP also is thought to account for 10 million physician visits per year in the United States. Symptoms of CAP include cough, fever, chills, fatigue, shortness of breath and chest pain.
About the Clinical Trials
Phase 3 clinical trials of Tygacil for CAP were conducted over a 24-month period in more than 200 countries across the globe. The first of their kind for Tygacil in the area of pneumonia, the clinical trials were multicenter, multinational, double-blind, randomized, controlled studies designed to compare cure rates between Tygacil and levofloxacin.
Tygacil was first approved by the FDA in June 2005 for the treatment of complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) in adults.
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 group (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 group (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 I.V. 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.
Important Safety Information
-- To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tygacil and other antibacterial drugs, Tygacil should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria.
-- Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life threatening.
-- Tygacil is contraindicated in patients with known hypersensitivity to tigecycline.
-- Tygacil should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics.
-- Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri and anti-anabolic action (which has led to increased BUN, azotemia, acidosis and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of Tygacil.
-- The safety and efficacy of Tygacil in patients with hospital-acquired pneumonia have not been established.
-- In clinical trials, the most common treatment-emergent adverse events in patients treated with Tygacil were nausea (29.5 percent) and vomiting (19.7 percent).
-- Tygacil may cause fetal harm when administered to a pregnant woman.
-- The safety and effectiveness of Tygacil in patients below age 18 and lactating women have not been established.
-- Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Tygacil, and may range in severity from mild diarrhea to fatal colitis.
-- Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective.
-- The use of Tygacil during tooth development may cause permanent discoloration of the teeth. Tygacil should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.
-- Prothrombin Time or other suitable anticoagulant test should be monitored if Tygacil is administered with warfarin.
-- Monotherapy should be used with caution in patients with clinically apparent intestinal perforation.
-- In patients with severe hepatic impairment (Child Pugh C), the initial dose of Tygacil should be 100 mg followed by 25 mg every 12 hours. Patients should be treated with caution and monitored for treatment response.
-- The following drugs should not be administered simultaneously through the same Y-site as Tygacil: amphotericin B and diazepam.
For a copy of Tygacil Prescribing Information, please visit www.wyeth.com.
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 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 based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our 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; data generated on our 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." 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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