Doctors treating patients with complicated urinary tract infections will soon have a new tool in their arsenal with the FDA’s Tuesday approval for Vabomere, a combination of the antibacterial meropenem and vaborbactam, a component to combat bacterial resistance.
The Medicines Company won approval for the new antibacterial, which is set for launch in the fourth quarter, the company said in a statement. The drug works by addressing bacteria that produce the KPC enzyme, which make up the majority of carbapenem-resistant Enterobacteriaceae that the CDC has called an “urgent antimicrobial resistance threat.”
“We look forward to a successful U.S. launch of Vabomere, leveraging our established, fully dedicated commercial infrastructure, and to expanding Vabomere into other global markets,” CEO Clive Meanwell said in a statement. The company will announce the med’s price at launch time, Leerink Partners analyst Joseph Schwartz wrote in a note to clients.
Medicines Company won a priority review with the med, and the antibacterial’s status as a Qualified Infectious Disease Product guarantees an additional 5 years of exclusivity, according to the pharma. Exclusivity on the antibacterial is expected to stretch into 2031. Schwartz, meanwhile, sees the product eventually racking up peak sales of about $400 million in 2028, but in the near term, he’s predicting $8 million in Q4 sales.
As Schwartz pointed out, Vabomere’s label is favorable for The Medicines Company; it includes specific pathogens and microbiological data that “could facilitate product adoption by infectious disease physicians.” Among those pathogens: Klebsiella pneumoniae, Escherichia coli, and Enterobacter cloacae, which “collectively are believed to cause the majority of Carbapenem-resistant Enterobacteriaceae (CRE) infections,” he wrote, adding, “we expect revenues to increase in not only the cUTI market but also in CRE infections.”
It’s been a big week for the drugmaker, which over the weekend delivered new data on next-gen PCSK9 candidate inclisiran. Results showed “robust lowering” of LDL cholesterol levels at both the six-month and one-year marks, Jefferies analyst Biren Amin wrote to clients, adding that company management “continues to explore strategic options around partnering while moving forward” with both the phase 3 and cardiovascular outcomes studies it announced in April.