Cempra Inc. is temporarily holding plans to seek European Medicines Agency approval for its treatment of community-acquired pneumonia in adults.
Cempra said it was withdrawing Solithromycin's marketing authorization application with the EMA since it would need additional data before the drug could be approved.
"By withdrawing the MAA at this time, Cempra will conserve considerable financial resources, and it will allow the company to align its strategy to provide additional data to both the EMA and U.S. Food and Drug Administration to support potential approval," the company said in a statement.
Cempra is conducting a phase 2/3 trial evaluating Solithromycin's safety and efficacy versus standard of care antibiotics in children and adolescents from two months to 17 years of age.
Solithromycin is also in development for uncomplicated urogenital urethritis caused by Neisseria gonorrhea or chlamydia.