More news in Theravance's ongoing battle to win approval for its antibiotic telavancin: the FDA has accepted the company's response to the approvable letter Theravance received in October [1]. Telavancin is a once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections, such as MRSA.
The FDA's approvable letter included a request for more clinical data or reanalyzed clinical data, revised labeling and a resolution of good manufacturing practices. Last week Theravance was scheduled to meet with the FDA, but that meeting was canceled because the agency wanted review the monitoring of study sites following data integrity concerns. Further action on the NDA won't be taken until the FDA is finished its evaluation. Theravance was a 2003 Fierce 15 [2] company.
"We are pleased that the FDA has accepted for review our complete response, which we submitted on January 21st," said Rick E Winningham, CEO of Theravance. "We are committed to working with the FDA to resolve the remaining issues on our cSSSI NDA."
- check out Theravance's release [3]
Related Articles:
Blog divines new FDA standard on data integrity. Report [4]
FDA wants more data on Theravance antibiotic. Report [1]
Theravance trumpets positive results of mid-stage trial. Report [5]
Astellas take a pass on Theravance's drugs. Report [6]
Links:
[1] http://www.fiercebiotech.com/story/fda-wants-more-data-theravance-antibiotic/2007-10-22
[2] http://www.fiercebiotech.com/Fierce15/2003/theravance
[3] http://www.fiercebiotech.com/press-releases/theravance-says-fda-review-response-antibiotic
[4] http://www.fiercebiotech.com/story/blog-divines-new-fda-standard-on-data-integrity/2008-03-04
[5] http://www.fiercebiotech.com/story/theravance-trumpets-positive-results-of-mid-stage-trial/2007-06-26
[6] http://www.fiercebiotech.com/story/also-noted-novartis-sinks-816-5m-italian-vaccine-plant-gsk-astellas-take-pass-theravances-drug