Half of Last Year's FDA and EMA Approved New Drugs Not Introduced Domestically... "17 Priority Imports Needed"

National Clinical Trial Support Foundation Releases '2021 Domestic Priority Report on Overseas New Drugs Not Yet Introduced'

[Asia Economy Reporter Kim Young-won] The National Clinical Trial Support Foundation has selected and disclosed 17 new drugs that were developed last year but have not yet been introduced domestically, prioritizing those that should be introduced first.

On the 13th, the foundation announced the "2021 Domestic Priority Report on Overseas New Drugs Not Yet Introduced," which analyzed 68 new drugs approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2021.

According to the report, among the 68 overseas approved new drugs, about half (35) have not been introduced domestically. Fifteen have already been approved, and 18 drugs are in preparation for introduction.

Through literature reviews, assessment of the application of overseas expedited approval programs, consultations with professional societies and clinicians, the foundation explored clinical importance and usefulness compared to existing drugs, ultimately selecting 17 drugs urgently needed for domestic introduction.

The top priority drugs included nine medications such as AstraZeneca's systemic lupus erythematosus treatment "Safnelo," Sanofi's Pompe disease treatment "Nexviazyme," and Calliditas Therapeutics' IgA nephropathy treatment "Nefecon" (U.S. brand name Tarpeyo). Among these, Nefecon recently received designation as an orphan drug from the Korean Ministry of Food and Drug Safety.

Second priority included three drugs such as UCB's psoriasis treatment "Bimzelx," while third priority included Regeneron's familial hypercholesterolemia treatment "Evkeeza," and fourth priority included four drugs such as Lantheus's prostate cancer PSMA PET imaging agent.

The foundation plans to investigate the reasons for non-introduction of drugs from global pharmaceutical companies and seek solutions, sharing the report with developers who have signed memorandums of understanding (MOUs) to facilitate the rapid domestic introduction of global new drugs. Furthermore, based on future collaboration with the Korea Orphan & Essential Drug Center, the foundation stated it will actively seek ways to promote the domestic introduction of non-introduced new drugs.

This content was produced with the assistance of AI translation services.