[약업신문]The Food and Drug Safety Administration approved 30 new drugs last year, including two domestically developed drugs

On the 27th, the Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) published the ‘2022 Drug Approval Report’, which includes last year’s drug approval and notification status.

Looking at the report, a total of 1,636 items were approved/notified as medicines last year. The main features are △approval of 2 new medicines (corona 19 vaccine and diabetes treatment) △approval of 8 items of COVID-19 vaccine △treatment of incurable diseases and rare 29 items were approved for orphan drugs to expand opportunities △ ‘metabolite drugs’ such as diabetes drugs in first place among drug effectiveness groups △ generic drug approval continues to decline.

Last year, the Ministry of Food and Drug Safety approved a total of 30 items for 22 ingredients. Among them, domestically developed new drugs are two items (two ingredients): a COVID-19 vaccine that injects antigens made with genetic recombination technology and a new ingredient diabetes treatment.

In addition, in a situation where the number of confirmed cases of Corona 19 increased again due to the spread of the Omicron mutation last year, the ‘bivalent Corona 19 vaccine’ which expresses all antigens of the initial virus and the mutant virus (Omicron BA. 1) A total of 8 Corona 19 vaccines were approved, including Corona 19 vaccines for infants (6 months to 4 years) and children (5 to 11 years).

By type, 6 mRNA vaccines and 2 recombinant vaccines were approved, and 3 items were approved for domestic manufacture.

Specifically, ‘Skycobione Multi Inj.’ is a COVID-19 vaccine developed and manufactured by a domestic pharmaceutical manufacturer, approved by the Ministry of Food and Drug Safety for the first time in the world. As a result, Korea has a Corona 19 ‘Leckironaju’ treatment (allowed on February 5, 2021) and a vaccine at the same time.

Last year, a total of 29 items from 22 ingredients were approved for orphan drugs. As various orphan drug items and ingredients have been approved over the past four years, treatment opportunities for patients with rare diseases such as refractory leukemia and relapsing multiple sclerosis, who had low medical access, have expanded.

According to effectiveness group, circulatory drugs, which came first in 2021, and metabolic drugs, which came second, came first with 629 items (43.3%) approved last year. Subsequently, last year, drugs for the nervous system, drugs for the circulatory system, and drugs for the digestive system were approved. We believe that market expansion, such as the recent decline in the age group of diabetic patients, has had an impact.

In terms of detailed classification, ‘diabetes concomitant drugs’ accounted for 41.3% of all approved items with 599 items, antipyretics/pain relievers/anti-inflammatory drugs 8.3% (120 items), other vitamins 4.6% (67 items), and other circulatory system drugs Drugs for the autonomic nervous system were 4.2% (61 items), and drugs for the autonomic nervous system were 3.0% (43 items), forming the top 5.

Last year, there was a reduction by half in the number of items approved/notified (1636 items) from 540 items (27.9%) compared to the previous year (2270 items).

The Food and Drug Safety Administration said, “We will continue to use the analysis data on drug approval and notification status for policy establishment, and continue to support drug product development by providing this information.”