Drug Update: September 2016 Issue 2

Specialty Update

FDA Delays Review of New Clostridium Difficile Drug

In January of this year, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for a new monoclonal antibody for the prevention of recurrent Clostridium difficile (C. difficile) infections. The BLA for the investigational antitoxin, bezlotoxumab, was granted Priority Review and a decision was expected by July 2016. However, in July the FDA requested more data from the new drug’s clinical trials and announced the decision would be delayed by three months. A decision regarding approval of bezlotoxumab is now expected by October 23rd of this year. Read more

Drug Update: September 2016 Issue 1

New Drug Approvals

New Oral Formulation of Drug for Opioid-Induced Constipation

This summer, the Food and Drug Administration (FDA) approved an oral formulation of Relistor® (methylnaltrexone bromide) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Methylnaltrexone was first approved in 2008 as a subcutaneous injection for the treatment of OIC in adults receiving palliative care, and in 2014 the indication was expanded to adults with chronic non-cancer pain. The 150 mg oral tablets are expected to be commercially available in the third quarter of 2016. Read more