2016 Was Not a Good Year for New FDA Anti-infectives
April 1, 2017 2 minutes read
By Stan Deresinski, MD, FACP, FIDSA
Clinical Professor of Medicine, Stanford University
Dr. Deresinski reports no financial relationships relevant to this field of study.
SYNOPSIS: In 2016, two anti-hepatitis C virus combination drugs were approved, as were monoclonal antibodies directed at bacterial toxins (anthrax toxin and Clostridium difficile toxin B), as well as an oral cholera vaccine.
SOURCE: Mullard A. 2016 FDA drug approvals. Nat Rev Drug Discov 2017;16:73-76.
In 2016, the U.S. FDA’s Center for Drug Evaluation and Research approved 22 drugs, a decrease from the record level of 45 in the previous year. Among the reasons for this decrease was a large number of complete response letters (communications indicating that the drug application cannot be approved in its current form) issued, including for at least one antibiotic, solithromycin, for which additional safety information was required. Only four of the 22 approved drugs are anti-infectives, and two are directed at hepatitis C virus infection — elbasvir plus grazoprevir (Zepatier) for genotypes 1 and 4 and sofosbuvir and velpatasvir (Epclusa) for genotypes 1-6. Also approved were two monoclonal antibodies: obiltoxaximab (Anthim), directed against anthrax toxin, and bezlotoxumab (Zinplava), targeting Clostridium difficile toxin B. In addition, the Center for Biologics Evaluation and Research approved Vaxchora, an oral cholera vaccine.
Although progress has been made in incentivizing pharmaceutical companies in the development of anti-infectives, the 2016 experience is bleak. The two new anti-hepatitis C virus combinations are certainly of interest, particularly sofosbuvir plus velpatasvir because of its activity against all genotypes. The monoclonal directed against C. difficile toxin B, which reduces recurrences, may prove of value, but is likely to have cost issues that retard its use. On the other hand, a monoclonal antibody directed against anthrax toxin will have very limited use (it is hoped), especially in the United States. The oral cholera vaccine similarly will have limited use in this country, but is likely to be used widely (it can be hoped) in countries where cholera is endemic or epidemic.
Despite hopes for the future, the complete lack of antibacterials, antifungals, antiparasitics, or antivirals (other than directed against the highly lucrative hepatitis C virus market) is disturbing. It can be hoped that pharmaceutical companies will do better in the future.
In 2016, two anti-hepatitis C virus combination drugs were approved, as were monoclonal antibodies directed at bacterial toxins (anthrax toxin and Clostridium difficile toxin B), as well as an oral cholera vaccine.
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