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FDA official analysis: the use of accelerated channels in the approval of new drugs in the past 15 years Global regulatory dynamics

 Last Update: 2022-11-15
 Source: Internet
 Author: User

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The FDA can use 4 programs to speed up drug launch, including accelerated approval and breakthrough therapy therapy), Fast Track qualifications, and priority qualifications review）
。 At the same time, the FDA can grant orphan drug designation to an investigational therapy for diseases that treat fewer than 200,000 U.
S.
patients drugs), to promote their development
.
A few days ago, researchers from the US FDA published a paper evaluating
the use of these programs and their impact on new drug approvals for the first time.
The study found that the proportion of approved new drugs using these accelerated channels has increased significantly over the past nearly 15 years, and this trend is likely to continue
.

The proportion of approved new drugs using these accelerated pathways has increased significantly over the past nearly 15 years, and this trend is likely to continue
.

In this study, the researchers analyzed the approvals of 581 innovative indications by the US FDA Drug Evaluation and Research Center (CDER) in 2008~2021, including the approval of the first New Drug Application (NDA) and Biologics License (BLA), as well as the approval
of Supplemental New Drug Application (sNDA) and Supplemental Biologics License (sBLA) for new indications.

The approval of 581 innovative indications by the US FDA Drug Evaluation and Research Center (CDER) in 2008~2021 was analyzed

The analysis showed that the proportion of applications approved for indications using at least one accelerated channel increased from 42.
3% in 2008 to 74.
5%
in 2021.
With the exception of 2009 and 2010, more than 50% of biologics used at least one accelerated channel
each year from 2008 to 2021.
According to the distinction between orphan drugs and non-orphan drugs, it can be seen that the increase in the frequency of accelerated channel use is mainly driven
by non-orphan drugs.

The increase in the proportion of applications approved for indications using at least one accelerated channel increased from 42.
3% in 2008 to 74.
5% in 2021.
The increase in accelerated channel frequency was mainly driven by non-orphan drugs

▲The proportion of approved applications using at least one acceleration channel in 2008~2021 (Image source: Reference [1])

A categorization of approved applications by therapeutic area shows that there are therapeutic areas that use accelerated channels particularly frequently
.
For example, 92.
7% of indications for cancer and 94.
4% for infectious diseases used at least one acceleration channel
.

At least one accelerated channel
was used in 92.
7% of cancer indications and 94.
4% of infectious disease indications.

▲Data on the use of different acceleration channels for approved applications in different fields (Image source: Reference [1])

In 2008~2021, a total of 82 indications were approved with accelerated approval, of which 79.
3% were anticancer drugs
.
Accelerated approvals for oncology indications reached 43.
3% compared to 3.
5%
for non-oncology indications.
Meanwhile, 85.
4 percent of applications for accelerated approval were granted orphan drug status, of which 78.
6 percent were oncology drugs
.
This reflects the trend
of developing precision therapies in the field of oncology by continuously segmenting patients through biomarkers.

Accelerated approval was granted for 82 indications, of which 79.
3% were anti-cancer drugs
.
43.
3%3.
5%

▲Data of approved applications for accelerated approval (Image source: Reference [1])

The study authors note that these results show that the use of accelerated channels is an important part
of the process of driving new drugs to market.
Orphan drug-qualified drugs are more likely to qualify for other accelerated pathways, helping
patients with rare diseases with significant unmet medical needs to access therapies in a timely manner.

Orphan drug-qualified drugs are more likely to qualify for other accelerated pathways, helping
patients with rare diseases with significant unmet medical needs to access therapies in a timely manner.

Going forward, the researchers say the use of acceleration channels is expected to continue to increase
.
Because the number of drug candidates eligible for orphan drug status has increased fourfold over the past 30 years, this means that the drug base that is more likely to use accelerated pathways has increased
significantly.
The increase in the number of orphan drug eligibility is mainly related to the increase in orphan drug eligible oncology indications, in addition, there is also a significant increase
in orphan drug eligible pediatric indications (such as cystic fibrosis, Duchenne muscular dystrophy, sickle cell anemia, etc.
).
In this study, 85.
4 percent of applications approved for accelerated approval earned orphan drug status
.
Given the trend of segmenting patient populations in new drug development, it is likely that more drugs will be orphan drug designation in the future and will try to accelerate their marketing
approvals.

Over the past 30 years, the number of drug candidates eligible for orphan drug status has increased fourfold

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