NDA of FDA in 2017 Q2: Total Number of New Drugs Approved Having Surpassed That of the 2016

With a half of 2017 past, unlike the downturn experienced in 2016, the new drug approval of FDA in 2017 can be called sailing with the wind: the total number of drugs approved by FDA just in the past two quarters has surpassed that of the year of 2016, and many drugs have obtained the accelerated approval of FDA in different forms. This article focuses on analyzing and interpreting the new drugs approved by FDA in 2017 Q2. Overall, 11 new drugs in total were approved the marketing by FDA in 2017 Q2, including 9 new molecular entities (NME) and 2 biologics license applications (BLA).

2017 is a year worth expecting. With regard to policies, the U.S. pharmaceutical industry will usher in important changes, with Donald Trump having become the President of the U.S.; and the Commissioner of FDA, the "public health gatekeeper" of the U.S., was changed on May 11, 2017, with the controversial Scott Gottlieb taking office; there will be important changes to the medical and pharmaceutical product regulatory policies, with the very clear signs being FDA’s recent active removal of opana ER, a kind of opioid pain medication, from market on the ground of illegal use, and the launch of the priority review of generic drugs. With regard to new drugs, the tumor immunotherapy has received more and more attention, and has also updated concepts for tumor clinical control; and monoclonal antibody drugs, CAR-T Therapy, and critical disease (such as leukemia and urothelial carcinoma) drugs have been achieved continuous breakthroughs.

I. First half of 2017: number of monoclonal antibodies reached a historical high, with various "acceleration" measures implemented

In the many high-quality new drugs approved the marketing by FDA in the first half of 2017, firstly, the number of monoclonal antibody drugs approved continued to set new records: monoclonal antibody drugs accounted for 6 in the 23 drugs approved in the first half of 2017, with the number approved constantly setting new records; secondly, many high-quality drugs were approved the marketing: having been a model in the world pharmaceutical community, FDA has world influence in drug approval and policy reform, and there were 9 in the 23 new drugs approved in the first half of 2017 were the first in their class; thirdly, various "acceleration" strategies were implemented: FDA adopts the accelerated approval policy for innovative drugs, breakthrough drugs, clinical imperative drugs, and rare disease drugs, with breakthrough therapy designation, priority approval, fast track and orphan drug status being the common accelerated approval measures of FDA; among the 23 new drugs approved in the first half of 2017, 43% (10) drugs received breakthrough therapy designation, 57% (13) drugs received priority approval, 30% (7) drugs received fast track, 35% (8) drugs received orphan drug status, and 3 drugs received accelerated approval, with the total of drugs approved the marketing far higher than the levels in the same period of previous years.

II. Summary of new drug approval in 2017 Q2: 11 new drugs marketed, with 2 monoclonal antibody drugs

I have also summarized and interpreted the new drug approval situation of FDA in 2017 Q1, therefore, no further comments will be made here, and the details may be seen in Analysis of New Drug Approval of FDA in 2017 Q1: Drugs Approved in the 3 Months were Nearly Half of the Quantity Approved Last Year. EvaluatePharma issued a report in June 2017 to make authoritative forecast and interpretation of the pharmaceutical market, and R&D, etc. According to the report, the R&D investment of the pharmaceutical industry will continue to grow, and the investment for marketing of a new product will reach as high as USD 5.1 billion. New drug R&D requires high investment and long cycle, but their lifecycles are being shortened dramatically, therefore, the companies pay very close attention to the future expectations of new drugs. There are also some drugs among the 11 new drugs approved in 2017 Q2 (see the attached table) having received high attention of the market and capital, specifically:

1. AstraZeneca has moved strongly into the competition of PD-1/PD-L1 antibody market upon Imfinzi. Undoubtedly, the tumor immunotherapy is one of the hottest fields in recent years, and the immunotherapy has indeed brought novel tumor control concepts to us, wherein, PD-1/PD-L1 pathway antibody is very popular. The Imfinzi of AstraZeneca is the 5^th PD-1/PD-L1 pathway antibody approved the marketing that targets PD-L1 and is approved to be used for patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression following platinum-based standard regimen treatment. According to one report issued by Endpoint news, the sales peak of this antibody of AstraZeneca will reach USD 2.3 billion, definitely a blockbuster-to-be.

2. The first drug for tardive dyskinesia was approved. Tardive dyskinesia is a central nervous system disease that results in involuntary, repetitive movements of trunk, extremities and face, and has a broad patient group. This new drug selectively targets the protein VMAT2, reduces dopamine-producing, and may be taken together with antipsychotics or antidepressants. The approval of this drug provides an effective control over patients with tardive dyskinesia. Endpoint news also thought highly of the drug, and forecast the sales to exceed USD 970 million.

3. Kevzara for moderate to severe rheumatic arthritis was marketed. As a monoclonal antibody drug targeting interleukin-6 (IL-6) receptor, Kevzara can effective remit moderate to severe arthritis. According to the report of EvaluatePharma, sarilumab was forecast to reach the sales peak of USD 1.8 billion in 2020.

4. Many first-in-class drugs were approved the marketing. Besides the above two drugs that receive much attention, the drugs marketed in 2017 Q2 are also of very high quality, with many being the first-in-class drugs, for example, Austedo is the first deuterated product, Brineura is the first drug specific to neuronal ceroid lipofuscinosis, and Radicava has been the first effective therapy approved for amyotrophic lateral sclerosis (ALS) over the 22 years, which provides more options for treatment of ALS.

By Tang