Expanding treatment opportunities for incurable and rare diseases by approving 29 orphan drugs
629 items of ‘metabolite drugs’ including diabetes drugs were approved, coming first in all efficacy groups
Reduced trend of generic approval due to limited number of clinical trial data sharing items
Last year, 30 new drugs, including a new Corona 19 vaccine developed at home, were found to have been approved.
On the 27th, the Ministry of Food and Drug Safety published the ‘2022 Drug Approval Report’, which includes last year’s drug approval and notification status.
Last year, a total of 1,636 drugs were approved/notified: 2 new domestically developed drugs (Corona 19 vaccine/diabetes treatment), 8 COVID-19 vaccines, 29 orphan drugs to expand treatment opportunities for incurable and rare diseases Mae’ It is worth noting that ‘metabolite drugs’ such as approved drugs and anti-diabetic drugs were in first place among drug efficacy groups, and the decline in generic drug approvals continued.
First, 30 items and 22 ingredients were approved for new drugs, and among them, two new drugs developed in Korea were a COVID-19 vaccine that injected antigens made with genetic recombination technology and a new ingredient diabetes treatment.
The new domestically developed drugs were Skycorbyone Multi (SARS coronavirus-2 surface antigen vaccine (genetic recombination)) and Enblo Tab. 0.3mg (Inavogliflozin). The number of approved new drug items developed domestically ranged from 0 in 2019 and 2020 to 5 in 21 and 2 in 2022.
In particular, in a situation where the number of confirmed cases of COVID-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) and ‘infants (6 children) A total of 8 Corona 19 vaccines have been approved, including Corona 19 vaccines for ‘children (5-11 years)’ and ‘children (for 5-11 years) ‘.
By type of vaccine, 6 mRNA vaccines and 2 recombinant vaccines were approved, and 3 items were approved for domestic manufacture.
The ‘Skycobione Multi Inj.’ licensed as a COVID-19 vaccine developed and manufactured by a domestic pharmaceutical manufacturer. , the capabilities and health security systems that can preemptively respond to future infectious disease epidemics have been demonstrated.
Last year, 29 items (22 ingredients) of orphan drugs were approved. 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. It is analyzed that this is a coincidence between the support at government level to promote the development of orphan drugs and the strategy of pharmaceutical companies to take advantage of the market with unmet demand.
The number of orphan drugs approved varies from 11 items (9 ingredients) in 2019 to 24 items (14 ingredients) in 2020, 22 items (19 ingredients) in 2021, and 29 items (22 ingredients) in 2022.
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, drugs for the nervous system, drugs for the circulatory system, and drugs for the digestive system were approved last year.
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.
In 2022, the number of drug approval/reporting items decreased by 540 items, or 27.9%, compared to the previous year’s 2270 items, and the number of 804 approved/notified items such as generic drugs decreased to half of the 1614 items the previous year. . It is assumed that this is due to the impact of a policy limiting the number of items that can share the same clinical test data (bioequivalence) to three by revising the Pharmaceutical Affairs Act in July 2021.
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