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Doctors raise concerns over Hyundai Pharm’s abortion pillBy Shim Woo-hyun
Published : July 15, 2021 - 16:46
Medical experts are divided over the safety and efficacy of an abortion pill poised to soon hit local pharmacy shelves.
After a Korean firm sought to bring in the drug Mifegyne -- which is sold in over 70 countries -- under a local brand name Mifegymiso, a group of local experts on Thursday called for a bridging study to verify the pill’s safety and efficacy.
A bridging study on a drug is an additional study executed in a new region to compare it with foreign clinical data on safety, efficacy, and dose response.
Previously, the Ministry of Food and Drug Safety decided to skip a bridging study on Mifegymiso and review the existing clinical data.
The Korean Association of Obstetrician & Gynecologists, however, argued that pharmacological variables could potentially occur by taking Mifepristone and Misoprostol at the same time.
Mifegymiso consists of one tablet of Mifepristone and four tablets of Misoprostol. Mifepristone, formerly RU-486, is known by the brand name Mifegyne in Korea.
If the ministry asks Hyundai Pharm to conduct a bridging study in South Korea with local patients, the introduction of the abortion pill could be postponed for as long as one year.
Meanwhile, a medical expert from the Association of Physicians for Humanism has claimed that it is safe enough to skip a bridging study on Mifegymiso, given that the Mifepristone and Misoprostol are already being widely used.
Mifepristone, also is known as Mifegyne, has been approved in around 70 countries, including the US, China and Thailand, according to Gynuity Health Projects, a US-based research and technical assistance organization.
Misoprostol tablets are currently used for inducing labor in South Korea as well.
In March this year, Hyundai Pharm signed an exclusive agreement with Linepharma International to sell Mifegyne in the Korean market. Hyundai Pharm earlier this month filed an application for authorization to market Mifegymiso in South Korea.
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