The U.S. Food and Drug Administration has accepted The Medicines Company’s new drug application filing for Intravenous Antibiotic Carbavance for priority review, the company said in a news release.
Carbavance treats complex urinary
tract infections and other infections from bacteria
resistant to already-existing carbapenems. The Medicines Company said it filed the application based on the results from the Phase III TANGO 1 clinical trial in patients with cUTIs, which satisfied pre-specified endpoints set by the FDA and European Medicines Agency.
Carbavance has been granted Fast
Track status and has been designated by
the FDA as a Qualified Infectious Disease Product, as authorized under
the GAIN Act, the company said.
exceptionally rapid development of Carbavance demonstrates the strong product
discovery and development capabilities of The Medicines Company’s Infectious
Disease Business, and reflects our commitment to making innovative
antimicrobial products available to patients with the most serious
The Medicines Company CEO Dr. Clive Meanwell said. “We believe that Carbavance could be a promising and
highly-differentiated treatment option for these patients and we look forward
to continuing our dialogue with the FDA during its review process.”
FDA accepts priority application for urinary tract infection treatment
Organizations in this Story
Want to get notified whenever we write about The Medicines Company ?
Next time we write about The Medicines Company, we'll email you a link to the story. You may edit your settings or unsubscribe at any time.Sign-up for Alerts