Nature issue: FDA may approve new drugs in 2020
Release date: 2020-01-14 Views: 0
In 2019, the FDA's Center for Drug Evaluation and Research (CDER) approved a total of 48 new drugs for marketing. Although the number is lower than 59 in 2018, this number is still the third highest in the past 25 years.
The average number of new drugs approved by the FDA for the past five years has reached 44, which is twice the average number of new drugs approved (22) in 2005-2009.
FDA's policy incentives for new drug approvals can also explain this growth trend. Of the new drugs approved in 2019, 28 (58%) were approved by priority review, 21 (44%) had orphan drug qualifications, 13 (27%) had breakthrough therapy qualifications, and 9 (19%) Accelerated approval was obtained with an alternative endpoint. However, it is worth pointing out that there are many new drugs approved for marketing in six months in the priority review mode in 2019. Thanks to the "priority review voucher" system issued by the FDA, many of them could only enter the standard review. The program's new drug has entered the fast track for approval.
In terms of the distribution of treatment areas, oncology drugs still have the highest proportion of new drugs approved in 2019, which is comparable to the average level of the past five years (23% vs 25%). A significant difference is that in 2019, 9 (19%) neurological products and 6 (13%) non-tumor blood diseases drugs were approved, a significant improvement over the average of the past 5 years. At the same time, only five (10%) anti-infective drugs were approved in 2019, a significant decrease compared to the past five years, and new drugs in metabolism and endocrinology have achieved nothing.
In terms of drug categories, the FDA approved 35 small molecule drugs (polypeptides below 40 amino acids are also classified as small molecule drugs), 10 protein drugs, and 2 oligonucleotide drugs in 2019. Protein drugs include one Nanobody drug and three antibody-conjugated drugs.
The FDA's Center for Biological Products Evaluation and Research (CBER) has also approved a number of long-awaited drugs in the industry, including Ebola vaccines and gene therapies.
According to Cortellis data predictions, many of the new drugs approved in 2019 can become blockbusters with annual sales of more than $ 1 billion in 2025, of which 5 products can reach annual global sales revenue of $ 3 billion. Among them, the highest sales forecast is Verka Pharmaceuticals' Trikafta for cystic fibrosis, which reached $ 4.5 billion. AbbVie's Risankizumab is expected to reach US $ 4.1 billion in global sales in 2025, which will help save Adamamumab's US patent cliff crisis in 2023.
However, the overall market competitiveness of new drugs approved in 2019 seems to be insufficient. Boston Consulting Group analysis data shows that the overall peak sales of new drugs approved in 2019 is $ 44 billion, the average sales peak of each new drug is about $ 900 million, and the median sales peak is $ 400 million. This set of figures is lower than the average sales peak of $ 1.2 billion and the median sales peak of $ 500 million for new drugs launched in the past 20 years.
A number of new drug applications for marketing were rejected by the FDA in 2019, and some of these new drugs that received a complete response letter (CRL) may resubmit their marketing applications in 2020.
Looking at the global new drug development pipeline in 2020, the number of new drugs expected to be approved for marketing this year is still considerable. Some new drugs with great market prospects are already under review.
Nature Reviews Drug Discovery. 2019 FDA drug approvals
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