The good news is that the U.S. FDA’s complete response letter (CRL) for Venatorx Pharmaceuticals Inc.’s intravenous antibiotic combination, cefepime-taniborbactam, in complicated urinary tract infections (cUTIs) requested no additional clinical testing. The bad news is the inevitable delay for a drug Venatorx and partner Melinta Therapeutics Inc. are aiming to position as a much-needed option for the fight against drug-resistant gram-negative infections.
Concerns voiced during January’s U.S. FDA advisory committee meeting failed to deter Cidara Therapeutics Inc. from winning approval by the agency March 22 for once-weekly Rezzayo (rezafungin for injection) to treat a pair of indications – candidemia as well as invasive candidiasis (IC) – in adults with limited or no alternatives.
The warning bells about the global threat of the rise of antimicrobial-resistant (AMR) infections and dearth of new antibiotics seem to have been ringing for several years now. However, the prospects of companies developing new antibiotics, buoyed by regulatory incentives and grant funding, should on the face of it be an attractive proposition for investors.
There has been a flurry of news flowing from companies developing new antibiotics during the month and the BioWorld Infectious Diseases index, after languishing for the past several months, is tracking up 5% for October. The activity comes against the backdrop of the completion of the AMR Challenge.