Wyeth Pharmaceutical (NYSE:WYE) announced that the FDA has accepted the filing of Tygacil (tigecycline) for new drug approval. Tygacil is a first-in-class antibiotic for the treatment of patients with community acquired pneumonia.
The next step is for the FDA to review the application and either approve or disapprove the request. It may also request additional data or take other actions.
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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 submission included data from two clinical studies of 846 patients. The study found that 89.7 percent of patients treated with Tygacil were cured as opposed to 86.3 percent who were treated with levofloxacin, an existing treatment for community acquired pneumonia.
Due to growing antibiotic resistance there is a need to develop new options to treat illnesses like community acquired pneumonia. Tygacil has shown to treat a number of illnesses. For a more complete list please read the PRNewsWire press release.
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» Wyeth from PharmaGazette
Wyeth finds itself in the #12 spot of 15 for research and development budget with $2.35 bn EUR and #10 in overall sales for 2006. 2007 was a tough year for the company as its 3 big drug candidates, bifeprunox,... [Read More]
Tracked on: December 14, 2007 10:13 AM | Permalink to Trackback