Wyeth Pharmaceuticals, a division of Wyeth, announced that the US Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application (sNDA) for its first-in-class antibiotic Tygacil (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. 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," said Gary L. Stiles, M.D., executive vice president, chief medical officer, Wyeth Pharmaceuticals.

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 hospitalised with CAP, and levofloxacin - an existing treatment option for CAP - cured 86.3 per cent of studied patients. The most common adverse events for Tygacil were nausea (24.3 per cent), vomiting (16.0 per cent) and abdominal pain (5.7 per cent). The discontinuation rates due to adverse events for Tygacil and levofloxacin were similar (6.1 per cent and 8.3 per cent, 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," said Thomas File, M.D., chief of infectious disease services, Summa Health System in Akron, Ohio.

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 per cent of the total sum and hospitalised 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.

Phase III 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, randomised, 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) and complicated intra-abdominal infections (cIAI). 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).

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.

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. In clinical trials, the most common treatment-emergent adverse events in patients treated with Tygacil were nausea (29.5 per cent) and vomiting (19.7 per cent).

Tygacil may cause foetal harm when administered to a pregnant woman and also the use of medicine during tooth development may cause permanent discoloration of the teeth, said the company.

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, haemophilia, oncology, vaccines and nutritional products.