Overview of NDA of FDA in Q3: Nearly Half of the 11 New Drugs Possessing “Blockbuster” Potential

Three quarters of 2017 have passed. Time is the most objective judge and good things will always stand its tests. I have introduced in detail and shared many of the high-profile drugs approved by FDA in 2017 Q3. In general, FDA approved 11 new drugs in total (see the attached table for the details) in 2017 Q3, including one CAR T-cell product KYMRIAH approved by the Center for Biologics Evaluation and Research (CBER). Next, I will summarize and share information of the 11 drugs approved by FDA in 2017 Q3, and introduce some that attract much attention therein.

2017 Q3: New drugs "born with a silver spoon in their mouth"

There were 11 new drugs approved for marketing in 2017 Q3, flat with those of the previous two quarters. There were 34 new drugs in total approved for marketing by September 27, 2017, wherein, market prospects of many drugs are expected to be good, such as J & J’s new psoriasis drug IL-23 monoclonal antibody (Mab): guselkumab, world’s first CAR T-cell product KYMRIAH produced by Novartis, and HCV cocktail therapy of Gilead/AbbVie.

1. J & J’s new psoriasis drug: guselkumab, the first IL-23 mAb in its class

Humira, Ustekinumab, Etanercept, Daivobet (calcipotriol/betamethasone) and Infliximab are now dominating the psoriasis drug market, and guselkumab will continue to increase J & J’s voice in the psoriasis market: it brings patients clinical benefits better than those of Humira, and is forecast by the market research institution EvaluatePharma to reach USD 1.6 billion sales in 2022.

2. First extended adjuvant therapy for breast cancer: neratinib maleate will reduce mortality risk by 33%

This drug is the first extended adjuvant therapy approved for this type of breast cancer: HER2-positive breast cancer. The adjuvant therapies for patients with such cancer are an important part of the treatment plan. This drug also has received very positive market expectations and is expected to exceed USD 1.25 billion sales in 2022.

3. Cocktail therapy of Gilead/AbbVie

As noted by me repeatedly, the U.S. HCV drug market is undergoing a sharp contraction, and effective patients are decreasing rapidly due to the excellent complete remission rate of the direct-acting antivirals (DAA). How to survive the crisis? 1. Develop new HCV products to treat patients with refractory hepatitis C; 2. Actively develop overseas HCV drug markets, such as China. Gilead and AbbVie competing to land the Chinese market recently is a prelude.

The HCV cocktail therapies of Gilead and AbbVie provide new treatment options for patients with chronic hepatitis C and patients treated with sofosbuvir or NS5A inhibitor. Evaluatepharma is also full of hope about those two products and forecasts that Gilead’s Vosevi will exceed USD 1.14 billion sales while AbbVie’s Mavyret will reach USD 1.25 billion in 2022.

4. A new era: Novartis’ KYMRIAH goes down in history

The CBER approved world’s first CAR T-cell product KYMRIAH for marketing on August 30, 2017. Novartis‘ product and Kite Pharma’s product of the same kind have been the focus of attention, and the above cell product is still imperfect with a controversial price, however, Novartis’ KYMRIAH has led us into a new era and brought life miracles to some leukemia patients, and is expected to have nearly USD 1.0 billion sales in 2022.

Each new drug approved in 2017 Q3 is commendable, however, I cannot detail each of them due to the length limitations. In general, the quality of those 11 new drugs is quite high, including 4 that are first in their class, 3 with breakthrough therapy designation, 1 with orphan drug designation, and 5 with priority review.

By Tang