LONDON, Dec 29 (APM) - The U.S. Food and Drug Administration has rejected Cempra's antibiotic solithromycin as a treatment for community-acquired bacterial pneumonia (CABP) in adults, it was announced on Thursday.
U.S.-based Cempra said in a statement it received a complete response letter from the regulator saying that additional clinical safety information and the satisfactory resolution of manufacturing facility inspection deficiencies are required before the drug can be approved in the U.S.
The FDA did not request any further information on solithromycin's efficacy for CABP in the letter, said Cempra.
The letter follows an FDA panel review in November where advisers narrowly voted 7-6 that trial data supported the view that the drug's benefits outweighs its risk (APMMA 50307). The panel also voted 12-1 that the risk of hepatotoxicity with solithromycin had not been adequately characterised and discussing potential approaches to further characterise the existing liver safety information on the drug.
The drugs' safety issues were highlighted in a preliminary FDA review, which highlighted a possible link between the drug and a rise in liver enzymes (APMMA 50276).
These issues have not been resolved, with the FDA noting in its rejection letter to Cempra that the risk of hepatotoxicity had not been adequately characterised. In particular, it noted the size of the safety database is limited to 920 patients who received solithromycin at the proposed dose and duration, and is too small to adequately characterise the nature and frequency of serious hepatic adverse effects.
To address this, Cempra said the FDA has requested a comparative study involving 9,000 patients to evaluate the safety of solithromycin in patients with CABP and to enable exclusion of serious drug induced liver injury.
The regulator also said that the drug's labelling will need to include adequate information about the potential for hepatotoxicity, limiting use to patients who have limited therapeutic options and limitations regarding duration of therapy. A comprehensive plan for post-marketing safety assessment including an enhanced pharmacovigilance programme would also be required.
In addition, the FDA took issue with manufacturing facilities for the product owned by Wockhardt and Hospira. These deficiencies need to be addressed before approval.
Cempra said it plans to request a meeting with the FDA as soon as possible to discuss the issues identified in the rejection letter, including the design of the recommended clinical safety study.
David Zaccardelli, acting chief executive of Cempra, said: "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."
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