FDA Rejects Antibiotic NDA


Cempra’s community-acquired bacterial pneumonia antibiotic drug rejected by FDA.

Officials with the FDA have rejected new drug applications for Cempra’s community-acquired bacterial pneumonia (CABP) antibiotic, according to a press release from Cempra. The company received a Complete Response Letter (CRL) from the FDA regarding the new drug applications (NDAs) for its oral and intravenous solithromycin drug with multiple safety concerns.

Although Cempra’s solithromycin was evaluated for its safety and efficacy, the FDA is requesting a comparative study to evaluate solithromycin in patients with CABP. Cempra’s previous study was limited to 920 patients, which FDA officials noted was too small of a safety database to adequately characterize the risk of serious hepatic adverse events. In response, the CRL recommended evaluating the drug in a study of approximately 9,000 patients.

The CRL noted several other issues based on their review of Cempra’s NDA, including label requirements complete with adequate information about hepatotoxicity risks and patient use, as well as the need for a comprehensive post-marketing safety assessment plan. The CRL also requested resolution to deficiencies cited during recent inspections of Wockhardt Limited and Hospira, Inc manufacturing facilities.

“As the rates of antibiotic resistance continue to rise, there is an unmet medical need for new antibiotics to treat patients with CABP and Cempra is committed to working with the FDA to achieve the approval of solithromycin as quickly as possible,” David Zaccardelli, PharmD, acting chief executive officer of Cempra, said in a press release.


Cempra Receives Complete Response Letter From FDA For Solithromycin NDAs [press release]. Chapel Hill, NC. Cempra. http://investor.cempra.com/releasedetail.cfm?ReleaseID=1005708. Accessed Dec. 29, 2016.

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