FDA's Record Year: A Look at 2018 New Drug Approvals

Regulatory NewsRegulatory News | 07 January 2019 |  By 

The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).
The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017. Those figures do not include products approved by FDA's Center for Biologics Evaluation and Research (CBER) which are tracked separately.
The number of new products approved by CDER in 2018 was also nearly double the center's 10-year average of 33 approvals per year.
"While CDER approved 59 novel drugs in 2018, more than in any prior year, CDER, as always, focuses on the medical value of the approvals, not the number. We also approved new uses, new formulations, and new dosage forms for many already FDA-approved drugs that will help to advance patient care," FDA says.
Of the 59 novel drugs and biologics approved in 2018, 34 (58%) were orphan drugs and 19 (32%) were first-in-class therapies.
Continuing the trend seen across recent years, many of the newly approved products received one or more expedited development or review pathway designations.
FDA Expedited Pathways and Other Approval Attributes 2017 and 2018
Designation or Attribute 2017 (N = 46) 2018 (N = 59)
Orphan Designation 18 (39%) 34 (58%)
Fast Track Designation 18 (39%) 24 (41%)
Breakthrough Therapy Designation 17 (38%) 14 (24%)
Priority Review 28 (61%) 43 (73%)
Accelerated Approval 6 (13%) 4 (7%)
First-Cycle Approval 39 (85%) 56 (95%)
First Approved in US 36 (78%) 42 (71%)
In 2018 FDA also approved the first drug under the recently created limited population pathway for antibacterial and antifungal drugs (LPAD) pathway, Insmed's Arikayce (amikacin liposome inhalation suspension), which is approved to treat nontuberculous mycobacterial lung disease.
The agency also achieved a number of other firsts in 2018, including the approving the first drug to treat smallpox, SIGA Technologies' Tpoxx (tecovirimat); the first drug to treat a rare inherited form of rickets known as x-linked hypophosphatemia, Ultragenyx's Crysvita (burosumab-twza); and the first cannabidiol-based drug, GW Pharmaceuticals' Epidiolex (cannabidiol).
FDA, FDA Voices, Report


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