This time, let's take a look at the past and present of drug development by looking at the status of FDA approvals in Korea and abroad.

New Drug Development Approvals (Korea)

Past Status of New Drug Development Approvals

The development of new drugs by Korean pharmaceutical companies began in 1987 with the introduction of the material patent system.

In the late 1990s, government projects began to develop new drugs in earnest.

In 1999, 'Sanplazu', the first new drug for stomach cancer, was approved in Korea.

In 2003, the antibiotic 'Factive', the first new domestic drug, was approved by the U.S. FDA, making Korea the 10th country in the world to develop new drugs.

As of 2023, 36 new drugs have been approved in Korea.

Current Status of New Drug Development Approvals

So, what is the current status of new drug development?

The KDRI website provides information on the current status of new drug development in Korea.

Go to the KDRI website → "Domestic R&D Trends" → "Status of New Drug Development" page, and you can see the following information on the approval of new drugs in Korea.

(Reference: KDRI https://www.kdra.or.kr/website/03web02.php)

In fact, the overseas market for newly developed drugs is larger than the domestic market. In order to go to overseas markets, the FDA approval process is a must. So, let's take a look at the current status of FDA new drug approval.

New Drug Approval Status (FDA)

FDA Previous approvals

Thanks to the efforts of drug discovery researchers around the world, new drugs are discovered and approved every year. In the graph below, you can see the FDA drug development approvals over the past 9 years, from 2013 to 2022. In 2022, 37 new drugs were approved, the lowest number since 2016.

Here's a table showing the proportion of synthetic and biologic drugs approved over the nine years.

Source: FDA, Advancing Health Through Innovation: New Drug Therapy Approvals 2022, 2023,1.10.

FDA Current Approvals

In the first half of 2023, the FDA approved 30 new drugs.

When categorized by drug modality (=how a drug targets a target or how a drug exerts its effects), small molecule drugs accounted for 60% (18 approvals), biologics accounted for 37% (11 approvals), and gene therapy accounted for 3% (1 approval).

(Reference: Novel Drug Approvals for 2023)

Of particular note this year is that 7 drugs were approved under the accelerated approval pathway.

It is also noteworthy that many drugs were approved as first-in-class treatments. Here's a breakdown of the first therapies approved.

• Skyclarys (FDA approved February 2023)

Reata's NRF2 activator Skyclarys (active ingredient: omaveloxolone) became the first treatment to treat Friedreich's ataxia, a degenerative neuromuscular disorder.

• Daybue (FDA approved in October 2023)

Rett syndrome, a rare neurological disorder that affects almost exclusively girls, also gained a treatment option with the approval of Acadia Pharmaceuticals' IGF1 modulator Daybue (active ingredient: Trofinetide).

• Orserdu (FDA approved January 2023)

Menarini's treatment for metastatic ER-, HER2-, and ESR1-mutant breast cancer, Orserdu (trade name: elacestrant), became the first oral selective estrogen receptor agonist.

• Lamzede (FDA approved February 2023)

Chiesi Farmaceutici's Lamzede (active ingredient: velmanase alfa) was the first to receive FDA approval for the treatment of alpha mannosidosis, an extremely rare lysosomal storage disease.

• Joenja (FDA approved March 2023)

Pharming received approval for Joenja (leniolisib), the first treatment for patients with activated PI3K Delta syndrome, an ultra-rare autoimmune disorder characterized by recurrent respiratory infections and immune dysregulation with only 200 identified patients in the U.S.

Other drugs in the pipeline for FDA approval in the second half of 2023 

• Eli Lilly's donanemab (Aβ mAb/Alzheimer's)

• MSD's sotatercept

As these rare disease research breakthroughs begin to be approved one by one, the need for unmet therapeutic areas is expected to gradually decrease.

(References: National Foundation for Drug Development, https://kddf.org//ko)

Wrapping up

In this article, we looked at the current status of new drug development approvals in Korea and the FDA. It takes an average of 15 years and 2-3 trillion won to create a new drug, and the development cost and time are enormous. In order to create new drugs that the world needs faster, digital transformation of the pharmaceutical industry is becoming a hot topic. Next time, we will look at AI technologies that accelerate the drug development process. If you're curious, check out the following posts (Study AI drug discovery star with these 3 papers)