While COVID-19 has impacted almost every facet of our lives over the last few years, one area that it didn’t seem to have a huge impact on is drug approvals by the United States Food and Drug Administration (FDA). Average review time in the United States did not decrease either during the pandemic nor in the early months following the re-opening of businesses.
A recent analysis of Evaluate Pharma data shows that there was no slippage in the time taken to review novel drugs in the United States, on either a standard or priority basis. The data will certainly be of interest now that the FDA faces a challenge to its accelerated approval pathway from the Accelerated Approval Integrity Act. The legislation aims to put more pressure on the FDA to pull conditionally approved therapeutics whose makers do not quickly confirm their benefit. While the legislation was introduced on March 7, 2022, no action has been taken after its initial referral to the House Committee on Energy and Commerce as of the writing of this article.
According to the Evaluate Pharma data, FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 58 novel drugs in an average review time of just under 10 months. This speed follows an upward trend – as outlined below – over the last decade.
Interestingly, despite variability in the number of drugs approved over the last decade, the total sales expected to bring in by the approved drugs holds relatively steady. Fifth-year United States revenue, (i.e., 2026 revenue for drugs approved in 2021), stands at $24 billion for drugs approved in 2021, as compared to $19 billion and $30 billion for those approved in 2020 and 2019, respectively.It’s important to note, however, that when it comes to overall expected revenue, the annual revenue will likely vary significantly. For example, COVID vaccines Spikevax and Comirnaty have combined global sales of $106 billion in 2021-2022, but by 2026, it’s likely that their revenues will fall to the single-digit billions.
Other drugs approved in 2021 that are likely to become blockbuster drugs by 2026 are Novartis’ Leqvio, Argenx’ Vygart, Bristol/Bluebird’s Abecma, and Amgen’s Lumakras. 2021 also saw the controversial approval of Biogen’s Alzheimer’s drug Aduhelm, which has had varied fluctuations in its sales forecasts. Aduhelm was omitted from Evaluate Pharma’s analysis due to the unpredictability.
This news follows the news that the absolute number of novel United States drugs approved picked up slightly during the pandemic.