The Medicines Company’s cUTI antibiotic Vabomere to see uptake mainly as second-line treatment after likely FDA approval – experts

28 Jul 2017

The Medicines Company’s cUTI antibiotic Vabomere to see uptake mainly as second-line treatment after likely FDA approval – experts

The Medicines Company’s (NASDAQ:MDCO) Vabomere (meropenem-vaborabactam) will chiefly be used as a second-line option for complicated urinary tract infection (cUTI) following expected FDA approval, said experts. They were divided over Vabomere’s ranking among other second-line competitors and antibiotics in late-stage development, especially its biggest potential opposition, Achaogen’s (NASDAQ:AKAO) plazomicin.

All experts added Vabomere, formerly Carbavance, will see limited first-line uptake for cUTI in regions with high antibiotic resistance and in laboratory-confirmed cases of carbapenem-resistant enterobacteriaceae-caused (CRE) cUTI. Experts were also divided over the strength of ex-US second-line uptake, which will depend on regional differences in resistant organisms.

Experts agreed FDA approval is likely based on previous data, with the non-inferiority bar likely exceeded.

Vabomere’s PDUFA for cUTI is expected on 21 August, according to company filings. Analysts predict approval and peak sales of USD 870m-1.8bn. The new drug application is based on Phase III data from TANGO-1 (NCT02166476) trial in cUTI patients and interim TANGO-2 (NCT02168946) data in infections due to confirmed or suspected CRE. Vabomere works by neutralising the bacteria with vaborbactam’s beta-lactamase mechanism and then kills the bacteria with its marapenem component, said David Hilbert, managing director, Femeris Women's Health Research Center, Medical Diagnostic Laboratories, Hamilton, New Jersey.

Already a subscriber? Login to read the full article.