Drug Approvals Up in 2023

The US Food and Drug Administration (FDA) approved 18 more novel drugs in 2023 than it did the previous year. New drug approvals totaled 55 in 2023, compared with just 37 in 2022 and 51 in 2021, according to a Reuters report.

The FDA typically approves between 45 and 50 novel drugs a year, the report explained. In 2018, new drug approvals peaked at 59. “We’re back at those peak levels, which hopefully means that the [pandemic-related] workflow disruptions, staffing and bandwidth issues and, most importantly, communications with developers have hopefully been improving,” Ritu Baral, an analyst from the investment banking firm TD Cowen, told Reuters.

The analyst anticipates a similar number of drug approvals in 2024 as occurred in 2023.

New drugs with an active ingredient or molecule not previously approved that received a nod from the FDA in 2023 included the obesity drug Zepbound from Eli Lilly and the Alzheimer drug Leqembi from Eisai and Biogen.

In addition to the 55 novel drugs approved, five gene therapies earned FDA approval in 2023, Reuters noted. Among those approvals was an innovative sickle cell disease therapy from Vertex Pharmaceuticals and CRISPR Therapeutics.

“Our scientists can do a lot more, and from that perspective we are excited about what’s coming down the pipeline, not just in 2024, but beyond that,” John Stanford, executive director of the life sciences investor group Incubate, told the news provider.

With the rebound in novel drug approvals, analysts and investors are hoping for a similar rebound in investment in biotech firms, the article reported.

References

Mishra M, Jain P. US FDA approvals bounce back in 2023, sparking hopes of a biotech recovery. Reuters. January 2, 2024. Accessed January 9, 2024.