FDA Rejects Cempra's Pneumonia Antibiotic

Source: Reuters

Dec 29, 2016

The U.S. FDA has rejected Cempra's antibiotic, solithromycin, for treating community-acquired bacterial pneumonia (CABP).

Despite the drug receiving the blessing of an FDA panel last month, the agency rejected the med due to inadequate data on the drug's impact on the liver and manufacturing issues.

Solithromycin is a next-generation version of Sanofi's Ketek, a contraversial drug that was eventually discontinued after causing fatal liver problems.

The FDA recommended an additional 9,000-patient study -- which would come at a high cost for Cempa -- to rule out the risk of liver injury.

The FDA also cited deficiencies in recent inspections of the manufacturing plants owned by Wockhardt and Pfizer's Hospira unit -- where solithromycin would be manufactured -- and said the issues must be resolved before the drug can be approved.

Read the Reuters coverage