December 19, 2014
The Food and Drug Administration’s (FDA) approval of ceftolozane/tazobactam (Zerbaxa) signifies several significant milestones in the battle against antibiotic-resistant superbugs. It marks the halfway point in reaching the goal laid out by the Infectious Diseases Society of America’s (IDSA) 10 x ’20 Initiative, which in 2010 called for the development of 10 new systemic antibacterial drugs by 2020. Further, ceftolozane/tazobactam is the first of the five 10 x ‘20 antibiotics to address certain serious and resistant Gram-negative bacteria. The new antibiotic will provide doctors more options for treating complicated urinary tract and complicated intra-abdominal infections.
But even this important approval doesn’t address all of our antibiotic needs. Patients still face life-threatening infections for which additional new antibiotics are urgently needed. IDSA will continue to advocate for economic and regulatory incentives to help bring these new antibiotics to market, and for improved stewardship, data collection and diagnostics to ensure antibiotics are used appropriately.
Through 10 x ’20 and other initiatives, IDSA has long advocated for and worked with legislators to enact policies that reduce economic barriers to the development of desperately needed new antibiotics. The passage of the Generating Antibiotic Incentives Now (GAIN) Act in 2012 was an important first step, providing fast track status, priority review, and five years additional exclusivity for new antibiotics that treat serious or life-threatening infections. The approval of Cubist Pharmaceutical’s ceftolozane/tazobactam is proof that the GAIN Act is having an impact. However, more incentives are needed to ensure that a robust pipeline will be able to continue producing the antibiotics patients will need for years to come. As two key examples, IDSA continues to advocate for swift passage of the bipartisan Antibiotic Development to Advance Patient Treatment (ADAPT) Act and supports the introduction of the Promise for Antibiotics and Therapeutics for Health (PATH) Act, both of which will work to reduce regulatory barriers to the development of new antibiotics that address an unmet medical need.
IDSA applauds Cubist and other public and private industry enterprises dedicated to helping combat the rise of antibiotic-resistant bacteria – a true public health crisis – for their efforts to mitigate the sharp decline in the development of new antibiotics.
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