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: Eight new antibiotics received FDA approval from 2010-2015.

SOURCE: Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the fight against multidrug-resistant bacteria? A review of U.S. Food and Drug Administration-approved antibiotics, 2010-2015. Ann Intern Med 2016;165:363-372.

Deak and colleagues examined available information about the eight antibiotics that were approved by the FDA from 2010-2015. Four antibiotics (ceftaroline, dalbavancin, tedizolid, and oritavancin) were approved for use in acute bacterial skin and skin-structure infection, two (ceftolozane-tazobactam and ceftazidime-avibactam) were approved for both complicated intraabdominal and complicated urinary tract infection, one (fidaxomicin) was approved for treatment and prevention of recurrences of Clostridium difficile-associated diarrhea, and one (bedaquiline) was approved for multidrug-resistant pulmonary tuberculosis. Bedaquiline was the only drug approved for use in treatment of a multi-drug-resistant organism and was the only “first-in-class,” i.e., having a novel mechanism of action.

The median duration of the total of clinical trials reviewed by FDA was 6.2 years, with a median of eight months of FDA review. Individual trials lasted for a median of 18 months, having enrolled a median of 666 patients. All but bedaquiline were approved on the basis of non-inferiority endpoint trials.


Only two of the eight new antibiotics were developed by “Big Pharma,” while seven are marketed by the latter group — and they have had no qualms about maximally pricing their drugs. Despite lack of evidence of superiority, seven of the eight drugs were significantly more expensive than their clinical trial comparator agents based on public information at the time of their introduction. The single agent for which this was not true was tedizolid, but in the interval, a generic form of linezolid has become available, and the price of its oral formulation has decreased dramatically. On the other hand, in our experience, the price of ceftaroline has increased significantly since its introduction.

This study provides evidence that since the passing of the Generating Antibiotic Incentives Now (GAIN) Act in 2012, which provided faster review times by FDA as well as five years of exclusivity in addition to the seven years already available, the antibiotic universe is modestly improving, and the Infectious Diseases Society of America goal of 10 new antibiotics by 2020 — the “10 x ’20 Initiative” — may be reached. Of concern, besides the prices being charged by Pharma (despite the financially advantageous initiatives provided), is the lack of development of drugs with novel modes of action.