Cempra pulls EU antibiotic filing following EMA questioning

EMA
The offices of the European Medicines Agency

Cempra has pulled a filing for approval of its antibiotic candidate solithromycin in the European Union. The action, which comes three months after FDA knocked back the drug, was prompted by questions from the European Medicines Agency (EMA) that Cempra is currently unable to resolve.

Having reviewed the day 120 questions submitted by EMA, Cempra thinks it will need more data if it is to win approval for the ketolide antibiotic solithromycin in the EU. Cempra provided no details about what EMA asked. But the fact that it plans to use the additional data requested by FDA to take a second run at an approval in the EU suggests there is overlap between the issues raised by regulators on either side of the Atlantic.

FDA issued a complete response letter to Cempra regarding its submission for approval of its asset as a treatment for community-acquired bacterial pneumonia late last year. That setback centered on the need for Cempra to generate more safety data. Cempra tried to win approval on the basis of a 920-patient safety database. FDA wants Cempra to assess the effect of solithromycin on 9,000 patients to eliminate concerns about a link to serious drug induced liver injury.

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Cempra revealed EMA had also questioned the safety package supporting the submission a month ago. At that time, Cempra said EMA had suggested a post-approval clinical safety study, but that it also believed the regulator may ask for additional data before approving the candidate. That put the EMA filing in the same boat as the FDA submission.

“Our goal is to make solithromycin available in the EU to address an important unmet medical need. We believe the most efficient path to approval is to withdraw the MAA at this time and to resubmit it with the additional data requested by the FDA,” David Zaccardelli, acting CEO of Cempra, said in a statement.

Confirmation that solithromycin won’t win an imminent approval in the EU further dented Cempra’s shares. The stock traded down 7% premarket, adding to the losses triggered by the December CRL and the lukewarm reception FDA and its advisory committee gave to the submission in November.

If Cempra is to regain lost ground, it must allay the safety concerns of regulators while also getting its contract manufacturers—Wockhardt and Pfizer’s Hospira—to fix problems found by FDA inspectors.

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