FDA review inventory: 581 approvals in 14 years, which accelerated track is the most popular

On November 1, the Journal of the American Medical Association (JAMA) published a study analyzing FDA approvals for 581 new drug applications and new indications (including small molecules and biologics) between 2008 and 2021, including orphan drugs and non-orphan drugs, and found a significant increase in the proportion of new drug applications (including new indications) approved through the accelerated pathway process, and expects this growth trend to continue
.

FDA's accelerated track process includes Fast Track Qualification (FTD), Breakthrough Therapy Qualification (BTD), Accelerated Approval (AA), and Priority Review (PR).

Since a drug can be approved for multiple indications, and the accelerated pathway procedure may be different for each indication, the study uses the approved indications of each drug as the statistics
of new drug application approval.

The study shows that the FDA approved a total of 581 new drug applications between 2008 and 2021, of which 139 (23.
9%) were therapeutic biological products, 442 (76.
1%) were small molecule drugs, and a total of 252 (43.
4%) were orphan drugs
.

Of the 581 new drug applications, 330 (56.
8%) were prioritized, 203 (34.
9%) were fast-track, 115 (19.
8%) were breakthrough therapies eligible, and only 82 (14.
1%) were granted accelerated approval
.
The most common combination of accelerated track procedures was "priority review + Fast Track eligibility" (18%, 106/581), while the "breakthrough therapy qualification + Fast Track qualification" combination accounted for at least 0.
2% (1/581).

Overall, there has been a significant increase
in the number of new drug applications using the FDA-accelerated pathway process.
There were 363 new drug applications using at least one accelerated pathway procedure, of which 69.
8% (97/139) were biological drugs and 60.
2% (266/442)
were small molecule drugs.
However, a significant proportion of new drug applications (37.
5%, 218/581) did not receive the accelerated
pathway.
The number of new drug applications that have been granted at least one accelerated track has also increased significantly, from 42.
3% (11/26) in 2008 to 74.
5% (41/55)
in 2021.
In addition, with the exception of 2009 and 2010, more than 50% of new drug applications for biologics were granted at least one accelerated track qualification
each year.

Subsequently, the study also classified 581 new drug applications by orphan drug and non-orphan drug, and found that the increase in the number of new drug applications approved through the accelerated track may be related to
orphan drug eligibility.

Of the new drug applications that received at least 1 accelerated pathway procedure, 62.
0% (225/363) had orphan drug status; Of the new drug applications for at least 2 accelerated pathways, 69.
3% (178/257) had orphan drug status; Of the new drug applications that received at least 3 accelerated pathways, 78.
4% (76/97) had orphan drug status; Of the 4 accelerated track process new drug applications, 84.
6% (11/13) had orphan drug status
.
In addition, for small molecule drugs, except for 2012, the proportion of orphan drug applications using at least one accelerated pathway procedure remained above 75% per year, but the annual proportion did not differ much
.

Given the different needs for accelerated pathway procedures in different therapeutic areas, the study also analyzed approvals
in terms of therapeutic areas.
The results showed that the field of oncology drugs relied heavily on accelerated channels (92.
7%, 139/150), while the fields of anesthetics, analgesics, and urology drugs were less dependent (or even non-dependent).

"Over time, the use of the accelerated track program has increased, with priority review being the most commonly used procedure and accelerated approval being the least commonly used procedure
," the researchers said.
Drugs that use the accelerated pathway require fewer and smaller clinical studies and are more
likely to be taken by the FDA after marketing than drugs that do not use any accelerated pathway procedure.
”

Original link in English: https://jamanetwork.
com/journals/jamanetworkopen/fullarticle/2798005