Analysis of New Drug Approval of FDA in 2017 Q1: Drugs Approved in the 3 Months were Nearly Half of

2017 is a year worth expecting, with the innovative drug development nonstop.  At the beginning of April after the first quarter of this year just ended, I would like to analyze the drugs approved by FDA in the first quarter. FDA approved 12 new drugs (see the attached table for the details) in total in 2017 Q1, including 8 NMEs (new molecular entity) and 4 BLAs (biologics license application). The quantity approved apparently higher than that of the same period in 2016. I would like to make a generalization of those 12 drugs here.

I. Potential blockbuster drug prediction: Which will be the future blockbuster?

One tag of blockbuster drugs is the annual sales of over USD 1 billion. Blockbuster drugs are a powerful competition chip for pharmaceutical enterprises. Some among the 12 new drugs marketed in 2017 Q1 receive much attention from the market and possess much potential to become blockbuster drug. An article of Endpoint News forecast 15 would-be blockbusters in 2017, including Novartis’ Kisqali, TESARO’s Zejula, Sanofi’s Dupixent, and Roche’s Ocrevus.

1. Novartis’ Kisqali is a CDK4/6 inhibitor, has received breakthrough therapy designation and priority review, and brings an innovative therapy to HR+/HER2- metastatic breast cancer patients, with the peak revenue to possibly reach up to USD 1.5 billion;

2. TESARO’s Zejula is a PARP inhibitor, has distinct advantages over similar drugs, and can clinically significantly improve the progression free survival of recurrent ovarian cancer patients without inspection of BRCA mutation or other biomarker condition, with the forecast peak revenue to reach USD 1.79 billion;

3. Sanofi’s Dupixent also has bright market prospects, and is the first monoclonal antibody drug used for patients with eczema that is not well controlled; the drug has received much attention from the beginning of marketing (see New Drug of Sanofi/Regeneron Receiving Much Attention from the Beginning of Marketing: With Both Positive Market Prospects and Patent Litigation Risk for details), and is forecast to reach USD 4.1 billion sales in 2022 by EvaluatePharma;

4. Roche’s Ocrevus is also a game changing drug, is the first clinical therapeutic drug used for primary progressive multiple sclerosis, and is expected to become first choice of second or third line drugs, with the peak revenue expected to be USD 3.98 billion.

II. 5 drugs received priority review: Many breakthrough drugs were approved.

Adopting the accelerated approval policy for innovative drugs, breakthrough therapies and rare disease drugs, FDA offers the common accelerated approval measures including breakthrough therapy designation, priority review, fast track and orphan drug status, which is of great significance to the fast marketing of innovative drugs that are clinical imperative. According to statistics, 25% (3 new drugs) drugs received breakthrough therapy designation, 42% (5 drugs) approved drugs received priority review, 33% (4 drugs) reviewed drugs received fast track, and 25% (3 drugs) drugs received orphan drug status, being of great significance to fast marketing of innovative drugs and treatment and prevention of rare diseases.

FDA has always been the wind vane for review and approval of world’s innovative drugs. And it’s very important to pay close attention to the pharmaceutical approval dynamics, policy innovation, and drug safety. The marketing and market performance of drugs in the U.S. market are of great reference value to their future trend in the Chinese pharmaceutical market.