As the World Health Organization and others pine for new innovation in antibiotics, a combination option from Venatorx Pharmaceuticals and Melinta Therapeutics won't be able to help out the cause anytime soon as manufacturing issues have led to an FDA rejection.
In a complete response letter, the agency requested further chemistry, manufacturing and controls (CMC) plus related data on the drug and its testing methods and manufacturing process, the companies disclosed in a Friday press release.
However, the FDA did not flag any safety or efficacy issues nor request new trials to support approval.
The antibiotic combines approved beta-lactam cefepime, which is branded by Pfizer as Maxipime, and Venatorx’s beta-lactamase inhibitor taniborbactam. The candidate scored both FDA fast track and qualified infectious disease product designations, the latter of which could potentially mean an additional five years of exclusivity.
“While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam,” Venatorx CEO Christopher Burns, Ph.D., said in the release. “We are already hard at work generating the additional requested CMC data, and we will continue to work closely with the FDA so that we can make this important new medicine available to patients as quickly as possible.”
An estimated more than 3 million cUTI patients are diagnosed yearly and require antibiotic therapy that adds up to over $6 billion in annualized 30-day costs, according to the companies.
Venatorx and Melinta originally linked up in November to commercialize cefepime-taniborbactam in the U.S. Meanwhile, Italy's Menarini Group has commercialization rights in 96 countries spanning Europe, Latin America, the Middle East, North Africa and other regions. Everest Medicines is responsible for development, registration and commercialization in China, South Korea and certain Southeast Asian countries.
A phase 3 study of 661 adults with cUTIs saw 70% of participants achieving bacterial eradication and symptomatic clinical success, compared with 58% of patients on meropenem, an established beta-lactam antibiotic.
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