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.
“The 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 drug-resistant infections,” 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.”
