FDA rejects approval of novel oral antibiotic tebipenem Hbr, further increasing the threat of antibiotic resistance, says GlobalData

Following the news that the Food and Drug Administration (FDA) has denied marketing approval for Spero Therapeutics’ tebipenem Hbr;

Nancy Jaser, PharmD/MBA, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:

“There is a high unmet need for new oral antibiotics which are effective against multidrug-resistant bacterial strains. Filling this gap in the market could allow patients with a simple but drug-resistant UTI to be treated at home, rather than be hospitalized for IV antibiotic therapy which puts them at risk of contracting other hospital acquired infections. Spero Therapeutics’ tebipenem Hbr is a first-in-class oral carbapenem therapeutic option with the potential to begin filling this gap.

“Despite its recent failure to gain FDA approval, data from the pivotal Phase III trial (ADAPT-PO) show that oral tebipenem had similar efficacy results to IV ertapenem, the current standard of care, in treating patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). Safety data from 1,372 hospitalized patients in the trial show that tebipenem was well-tolerated with a similar safety profile to IV ertapenem. However, the FDA noted that further clinical data is required for approval.

“Given the urgent need for new oral antibiotics for cUTI and the positive data seen in the ADAPT-PO trial, it is likely that tebipenem will be fully approved once the additional data requested is provided. Tebipenem has been granted Fast Track and Qualified Infectious Disease Product (QIDP) designations by the FDA for the treatment of both cUTI and AP.”

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