Cipla’s withdrawal of antibiotic marketing application latest sign of AMR market failure

Cipla has withdrawn its application for EMA approval of Zemdri, an antibiotic it acquired in a fire sale from Achaogen after the biotech declared bankruptcy. Cipla stated that the costs of meeting pre- and post-approval requirements, including addressing EMA concerns about the methods used to sterilize the drug and implementing a pediatric investigation plan, made it commercially unviable.

Achaogen Inc. raised more than $500 million from the U.S. Biomedical Advanced Research and Development Authority (BARDA) and private investors to develop and obtain FDA approval for Zemdri plazomicin, which treats infections caused by antibiotic resistant Enterobacteriales, and a second antibiotic. ...