FDA denies Spero's UTI treatment
The FDA has rejected an application from Spero Therapeutics for its investigational treatment for complicated UTIs, according to a press release from the company.
Spero Therapeutics announced June 27 that it received a complete response letter from the FDA stating that the administration could not approve tebipenem pivoxil hydrobromide (tebipenem HBr) oral tablets because the company’s phase 3 study evaluating the drug “was insufficient to support approval” for complicated urinary tract infections (cUTIs) and additional clinical study is required.
“We continue to believe that tebipenem HBr offers patients and their providers an important new treatment option, that if approved, has the potential to address the critical unmet need for a new oral antibiotic for patients with cUTI,” Ankit Mahadevia, MD, chief executive officer of Spero Therapeutics, said in the release.
As Healio previously reported, the phase 3, international, double-blind, double-dummy trial, published April 7 in The New England Journal of Medicine, concluded that oral tebipenem HBr was noninferior and had a similar safety profile to intravenous ertapenem for the treatment of cUTI and acute pyelonephritis.
Mahadevia said that Spero is “disappointed with the FDA’s decision” but will continue to move forward to address the FDA’s concerns and outline “a clear path forward for tebipenem HBr.” The release also states that Spero will “promptly request a Type A meeting with the FDA to gain further insights as to the pathway forward towards a potential regulatory approval for tebipenem HBr.”
References:
- Eckburg, P, et al. N Engl J Med. 2022;doi: 10.1056/NEJMoa2105462.
- Spero Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Tebipenem HBr New Drug Application. https://investors.sperotherapeutics.com/news-releases/news-release-details/spero-therapeutics-receives-complete-response-letter-us-food-and. Published June 27, 2022. Accessed June 28, 2022.