New Drug Approvals in 2018 - Another Record Year!

Area of Science:

• Pharmaceutical Science
• Regulatory Science

Background:

• The US Food and Drug Administration (FDA) plays a crucial role in drug approval.
• Expedited review pathways are designed to accelerate the availability of important new medicines.

Purpose of the Study:

• To review the novel drugs approved by the FDA in 2018.
• To analyze the role of expedited review pathways in the record number of approvals.
• To identify the prevalence of rare disease treatments among novel drug approvals.

Main Methods:

• Review of FDA novel drug approval data for the year 2018.
• Analysis of approval designations, focusing on expedited pathways.
• Categorization of approved drugs by therapeutic area, with a focus on rare diseases.

Main Results:

• A record 59 novel drugs were approved by the FDA in 2018.
• 73% (43 of 59) of these approvals utilized an expedited review pathway.
• 58% (34 of 59) of the novel drugs were approved for treating rare diseases.

Conclusions:

• Expedited review pathways significantly contributed to the record number of novel drug approvals in 2018.
• A substantial proportion of novel drugs approved in 2018 were intended for rare disease indications.
• The findings highlight the FDA's efforts to expedite access to new therapies, particularly for underserved rare disease populations.