We must cheer for FDA: the Center of Drug Evaluation and Research (CDER) under FDA approved the marketing of 46 new drugs in total by December 21, 2017, successfully setting a new review record for the recent 20 years.

CDER has released the annual drug review report recently, which summarizes the drug review and approval situation of FDA in 2017, and is worthy of attention. It is undoubted that 2017 is another "good harvest year" in which the marketing review of 46 new drugs in total is completed at a high level, setting a new high for recent 20 years. In this article, the new drug review situation of FDA in 2017 is first overall reviewed, and then 11 that attract much attention among the 46 drugs are emphatically introduced, which are considered promising by the industry and expected to become future "blockbusters". It’s important to note that the drugs introduced herein include only those approved by CDER for marketing, and exclude the two CAR T-cell products approved by the Center for Biologics Evaluation and Research (CBER), namely, Novartis’ Kymriah (Tisagenlecleucel, CTL-019) and Kite Pharma’s Yescarta (axicabtagene ciloleucel).

I. Overview of new drug review of FDA in 2017: 46 NMEs, including 34 NDAs, and 12 BLAs

CDER under FDA approved 46 new molecular entities (NMEs) in total by December 21, 2017, including 34 NDAs and 12 BLAs. 2017 is undoubtedly a "good harvest year" compared to 2016, with number of new drugs marketed setting a new record for recent 20 years. In this part, we’ll have an overview of the new drug review of FDA in 2017.

Overview of new drug review of FDA in 2017

1. 46 drugs: the number of new drugs marketed reaches the highest level for recent 20 years

At the time of writing, FDA approved the marketing of 46 new drugs in total in 2017, far higher than the 22 in 2016, setting a new record for the recent 20 years. According to data, FDA received 48 marketing applications for NMEs (14% increase), 106 applications for non-NMEs (28% increase), and 232 supplementary applications (43% increase) by December 5, 2017.

FDA’s work is still fruitful. Share of the New Active Substances in the U.S. is still the highest among countries and regions in the world, which has a great relationship with the new drug review policies of the U.S. regulator.

The first action approval rate of NMEs reaches 71% in 2017, also the highest level over the years.

2. Fast Track, Breakthrough Therapy, and Priority Review supporting the fast marketing of innovative drugs

FDA has been the wind vane for review of world’s innovative drugs, of which the fast R&D and review regulatory policies for innovative drugs have quite important referential significance, such as Priority Review, Breakthrough Therapy, and Fast Track. Among the 46 drugs marketed in 2017, 29 (70%) were approved under Priority Review, 17 (43%) received Breakthrough Therapy designation, and 18 (45%) received Fast Track.

3. 17 orphan drugs: to continue the miracle of life

Orphan drugs are indicated for a very small number of patients, and some may be only for a thousand. FDA has been committed to the accelerated approval of innovative orphan drugs, and green channel for orphan drug approval. According to data, 17 drugs in total marketed in 2017 belong to orphan drug, with the orphan indications reaching 56, the highest over the years.

4. PDUFA reform: innovative drug review efficiency increasing rapidly

The sixth amendment of the Prescription Drug User Fee Act (PDUFA) was completed on August 18, 2017, to increase the communication efficiency and flexibility, and make adjustments to the advisory committee meetings. It’s worth noting that Biosimilar User Fee Act II will come into force in 2018 fiscal year, and the biosimilar approval and marketing will enter the fast channel.

All the 46 drugs approved in 2017 could meet PDUFA dates, showing high efficiency of FDA’s review

II. Future "blockbusters": the following new drugs particularly noteworthy

         USD 1 billion is an important tag of a blockbuster drug. The possessing of a "blockbuster" drug is of great significance to a company. There are some drugs considered promising by investors among those approved in the first half of 2017. Endpoint News forecast the sales of Dupixent, Ocrevus, and Durvalumab, etc. would exceed USD 1 billion in 2022, to become blockbuster.

#Data from Orphan Drug Report 2017

Certainly, 2017 also has witnessed the approval of the first CAR-T drug, and relevant CAR-T products of Gilead and Novartis have attracted attention of the world. It is hoped that this article could give researchers in the field an overview of new drug review in 2017. Sincerely look forward that those drugs could be marketed in China very soon.