Cempra pulled its European marketing authorization application for its embattled pneumonia treatment Solithera, which was denied FDA approval in January.
Cempra cited the need for additional data to answer Day 120 questions from the EMA. The company said withdrawing the EU application will save “considerable financial resources” and allow time to realign its strategy with both the EMA and the FDA.
Resubmitting the MAA with further data requested by FDA is the “most efficient path to approval,” said Cempra’s acting CEO David Zaccardelli. The FDA’s response letter listed manufacturing deficiencies observed during agency inspections of the manufacturers — Wockhardt and Hospira — and requested additional safety data on liver toxicity.
Last November, an FDA advisory committee narrowly backed approval of Solithera (solithromycin), by a single vote, and raised concerns over the drug’s safety and the sample sizes used in clinical trials.