A priority designation can be given to an new drug application (NDA) for Tygacil that, if approved, would be a significant improvement compared with existing treatments. Tygacil is the first in a new class of antibiotics called glycylcyclines to be submitted for regulatory approval.
Tygacil was designed to circumvent two major resistance mechanisms that have limited the use of many antibiotics: efflux pumps and ribosomal protection.
Wyeth Pharmaceuticals, a division of 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).
The Tygacil NDA submission included data from four pivotal phase III studies examining the safety and efficacy of Tygacil for the treatment of cIAI and cSSSI. The submission also included in vitro data against both gram- negative and gram-positive bacteria, anaerobes, and certain drug-resistant pathogens.
Concurrent with its NDA submission in the US, Wyeth also submitted a marketing authorization application (MAA) with the European Medicines Agency and additional filings with authorities in Australia and Switzerland on December 15, 2004. This was the first time Wyeth applied simultaneously for US and global approval of a new product.