The objective of this Guide is to offer payers, providers, and other healthcare stakeholders a comprehensive overview of new drugs approved by the US Food and Drug Administration (FDA) in 2019 and the first half of 2020. This practical tool offers a quick and detailed evidence-based resource for medical and pharmacy directors to guide their benefit design decision-making and the development of drug coverage criteria.
Because this Guide is published later in the year, this issue covers the recent developments in FDA drug approvals from January 1, 2019, through June 15, 2020.
In addition to a complete listing of all new molecular entities (NMEs) and new biologic license applications (BLAs) approved by the FDA in 2019 through June 15, 2020, this Guide provides a comprehensive list of new indications, new combinations, new dosages, new formulations, new patient populations, new biosimilars, as well as new blood products, new vaccines, and new gene therapies approved in the United States during that period.
New technologies continue to feature high in today’s drug development, with the ongoing introduction of new and improved biologic therapies, immunotherapies, and targeted therapies, while simultaneously making use of new testing and screening technologies to match the right patient with the right treatment.
Thus, the number of first-in-class drugs continues to grow, and many of the new drugs entering the market receive new indications soon after, in quick succession. In 2019 alone, among the 48 new NMEs and new BLAs approved by the FDA, 20 (42%) were classified as first-in-class medications. Furthermore, the trend of accelerating the drug approval process continues, as evidenced by the many drugs approved under the fast track or accelerated review pathway, as well as under the priority review process or are designated as breakthrough therapies.
Overall, in 2019, 17 of the new drugs received fast track designation, 28 had a priority review, 9 were approved under the accelerated approval pathway, and 13 were approved as breakthrough therapies. Applying these various expedited review tracks to the drug approval process continues to show the FDA’s commitment to innovation, by encouraging pharmaceutical companies to focus their research and development on novel life-saving medications, while giving patients earlier access to such essential therapies.
A key feature of this Guide is the comprehensive Directory of all the NMEs and BLAs approved by the FDA in 2019 through June 15, 2020, as well as a list of all new indications, combinations, formulations, dosages, patient populations, biosimilars, vaccines, blood products, and gene therapies.
This Guide also includes a select sample of comprehensive updates on some of the key new drugs and new indications approved by the FDA in 2019 and early 2020. Additional comprehensive updates of new drugs and new indications will be posted online together with the full Guide.
We hope you find this publication a useful tool for applying up-to-date information on new pharmaceuticals into benefit design decisions and patient care.
EDITOR’S NOTE: The FDA continues to make changes to the prescribing information of many drugs on an ongoing basis. Every effort has been made to update the information in each drug update and any other sections of this publication based on each drug’s prescribing information up to June 15, 2020. The Publisher is not responsible for any inaccuracies stemming from changes, new approvals, or company updates that became available after that date. Readers are advised to review the prescribing information for any future updates and revisions.