What Kind of Drug can be Called Miracle Drug?

There are evidently different definitions for the "miracle drug" in China and foreign countries. The "miracle drug" in China generally implies mockery, and refers to those that are only marketed in China, safe, but have no definite efficacy, and mostly belong to adjuvant drugs, or those that seem to cure all diseases, and have huge clinical dosages and large sales revenue, such as glutathione, radix isatidis and ribavirin.

However, the "miracle drug" in foreign countries is generally a good reputation people give to a drug, such as sofosbuvir that cures HCV, anti-PD-1 monoclonal antibody Keytruda that magically made the brain melanoma of President Carter disappear, and of course, those that have been proved in a large number of clinical trials, have super-extensive indications, and give people unlimited imaginary space, including metformin, Vitamin D, and adalimumab, etc.

Today, let’s see some "miracle drugs" in foreign countries that have a great many indications and annual sales of billions of or even over a hundred billion U.S. dollars.

1. Opdivo, Keytruda, Tecentriq

PD-1/PD-L1 inhibitors can relieve immunosuppression and activate human immune system to kill tumor cells. The 4 anti-PD-1/PD-L1 drugs marketed at present include BMS’ Opdivo, MSD’s Keytruda, Roche’s Tecentriq, and Pfizer/Merck’s Bavencio, of which the performance after the marketing could be described as skyrocketing.

Global sales of the 3 anti-PD-1/PD-L1 drugs (USD 100 million)

Note: Sales of Tecentriq were in CHF 100 million

Regarding the indication, the anti-PD-1/PD-L1 drugs are mainly developed for various solid tumors, and in the hematologic neoplasm field, they are mainly used to treat the classical Hodgkin's lymphoma. Opdivo has been approved for 6 indications, Keytruda has been approved for 4 indications, and Tecentriq has been approved for 2 indications so far. There are hundreds of clinical trials of anti-PD-1/PD-L1 drugs being conducted in full swing, with the indications newly approved to be continuously increased.

Indications and FDA approval dates of the 3 anti-PD-1/PD-L1 drugs

2. Lucentis, Eylea

Both Roche/Novartis’ Lucentis (ranibizumab) and Bayer/Regeneron’s Eylea (aflibercept) belong to angiogenesis inhibitor, with the difference that the former is monoclonal antibody drug while the latter is fusion protein. The earliest indication of both when they were marketed is wet age-related macular degeneration (AMD).

Lucentis has been successively expanded other 4 ophthalmic indications thereafter, including retinal vein occlusion (RVO)-induced macular edema, diabetic macular edema, DME patients’ retinopathy, and myopic choroidal neovascularization. The number of indications of Eylea is only one less than that of Lucentis.

Regarding the market performance, Eylea’s performance has surpassed Lucentis, with the 2016 global sales exceeding USD 5 billion, although it was marketed more than 5 years later than Lucentis.

It is worth noting that the Zaltrap (ziv-aflibercept) cooperated between Regeneron and Sanofi has also been developed for colorectal cancer.

3. Avastin

As a recombinant monoclonal antibody to human VEGF, and the world’s first anti-angiogenic drug widely applicable to multiple tumors, bevacizumab (Avastin) has been expanded indication to include non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, fallopian tube carcinoma, and peritoneal cancer, etc. since it was first approved by FDA to treat metastatic colorectal cancer on February 26, 2004, and it created the sales record of CHF 6.783 billion in 2016.

4. Humira, Remicade, Enbrel

Humira, Remicade and Enbrel are all large molecule biologics targeting TNFα, and belong to broad-spectrum drug in the autoimmune disease field, with a great many indications. Here, I would only take Humira for instance, as their mechanism of action is the same.

Humira was first approved by FDA to treat moderate to severe active rheumatoid arthritis on December 31, 2002, and was approved by EMA on August 9, 2003, and it has now over 10 indications approved.

Indications of Humira approved in the U.S. and EU

From the perspective of sales, Humira has advanced triumphantly, created a historical high of USD 16 billion in 2016, and has accumulatively achieved USD 94.5 billion sales revenue since the marketing.

5. Botox

BOTOX mainly contains the highly-purified Botulinum Toxin Type A which is a kind of nerve conduction blocking agent used to relax overactive muscles. As the name suggests, botulinum toxin is a kind of "toxic pharmaceutical product" subject to strict control, however, it has been approved to eliminate the glabellar frown lines in 2002 and therefore became a beauty product highly favored by females.

Indications approved for Botox

Botox global sales

It was really amazing that Botox’s sales revenue created a historical high of nearly USD 3 billion in 2016 as an old product marketed for over 20 years. Naturally, the successful market promotion has contributed a great share in extending Botox’s vitality.

The indications of Botox have been expanded to: prevention of migraine, and treatment of urinary incontinence and overactive bladder, etc. Allergan reported topline results from a Phase II study of Botox’s treatment of severe depression on the 5^th of this April, demonstrating that Botox 30U could significantly improve the severe depression score at week 3, week 6 and week 9 of the treatment compared to placebo, and reached the primary endpoint. Perhaps Botox could be used to treat depression very soon.

Data source: Pharmcube

Written by: Xiaoyaowan