Wyeth says it has won FDA approval for an expanded indication for pneumonia med Tygacil (tigecycline). The med will now be available for the treatment of adults with community-acquired bacterial pneumonia (CABP). The decision was based on the results of two randomized, double-blind conducted in 28 different countries and including 859 patients with CABP.
Tygacil was initially approved in 2005 for the treatment of complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI).
"The approval of this new indication is timely. Antibiotic resistance continues to grow and new antimicrobials are needed," says Joseph Camardo, M.D., Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals. "The approval of TYGACIL for CABP is an important milestone in Wyeth's commitment to exploring new treatment options in the anti-infective therapeutic area."
- read the Wyeth release [1]
Related Articles:
Breast cancer and Prempro revisited [2]
New concerns on Wyeth hormones [3]
Wyeth bails on European Pristiq app [4]
Wyeth pounces on Sandoz's copycat Protonix [5]
Links:
[1] http://www.fiercebiotech.com/press-releases/approves-new-indication-wyeths-tygacil-tigecycline-treatment-adult-patients-community
[2] http://www.fiercepharma.com/story/breast-cancer-and-prempro-revisited/2009-02-05
[3] http://www.fiercepharma.com/story/new-concerns-wyeth-hormones/2008-12-15
[4] http://www.fiercepharma.com/story/wyeth-bails-european-pristiq-app/2008-10-16
[5] http://www.fiercepharma.com/story/wyeth-pounces-sandozs-copycat-protonix/2008-05-21