Wyeth Pharmaceuticals, a division of Wyeth announced that the company has submitted a global registration dossier for its investigational antibiotic Tygacil (tigecycline). This is the first time Wyeth has applied simultaneously for global approval of a new product. This registration package included the submission of a New Drug Application (NDA) with the US Food and Drug Administration (FDA), as well as a Marketing Authorization Application (MAA) with the European Medicines Agency and additional filings with authorities in Canada, Australia, and Switzerland, a company release said.
Wyeth is seeking market approval for Tygacil as a single agent therapy to treat patients with complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI), caused by gram-negative and gram-positive pathogens, anaerobes, and both methicillin-susceptible and methicillin-resistant strains of Staphylococcus aureus (MSSA and MRSA).
"Tygacil is the first glycylcycline, a new class of antibiotic, with the potential to be a monotherapy option for clinicians treating complicated skin and skin structure infections and complicated intra-abdominal infections," says Dr Robert Ruffolo, president of Wyeth Research. "Complicated infections and antibiotic resistance are serious concerns around the world, and the hope is that Tygacil will provide the global medical community with a much needed treatment alternative."
According to the US Centers for Disease Control and Prevention (CDC), antibiotic resistance has become so widespread that many significant bacterial infections in the world are becoming resistant to commonly used antibiotics. Bacteria that have become resistant to previously effective antimicrobials include pneumococci, staphylococci, enterococci, E. coli, Enterobacter, and Acinetobacter.
Physicians face an increasing clinical challenge because current efforts to prevent and control antimicrobial resistance in the hospital and community are inadequate. In fact, more and more patients admitted to hospitals from the community are presenting with antibiotic resistant bacteria that were previously only found within the hospital environment. This issue is compounded by the fact that few broad-spectrum antibiotic agents are currently in development to fight existing and emerging resistant bacteria. According to a paper published in the medical journal Clinical Infectious Diseases in April 2004, just five of 31 anti-infectives currently in development at the world's 15 largest pharmaceutical companies are antibacterial agents.
"Increasing antibiotic resistance in hospitals can lead to treatment failure, poor patient outcomes, and increased cost," says Dr. Sherwood Gorbach, Professor of Public Health and Medicine, Tufts University School of Medicine. "In times where the antibiotic pipeline is declining, the filing of new antibiotics could not be more appropriate."
The submission included data from four pivotal phase III studies examining the safety and efficacy of Tygacil for the treatment of complicated skin and skin structure infections and the treatment of complicated intra-abdominal infections. The filing also included in vitro data against both gram-negative and gram-positive bacteria, and anaerobes, including drug-resistant pathogens. The most common adverse events associated with Tygacil in clinical trials were nausea and vomiting.