The government should require a bridging trial for Mifegymiso, an abortion pill under the regulator’s review for marketing approval, the Korean Association of Obstetricians & Gynecologists (KSOG) said.

Industry watchers had expected that the government could exempt a bridging study because Mifegymiso has already been used in other parts of the world, including the U.S., Europe, and Vietnam.

The Ministry of Food and Drug Safety (MFDS) also said that most experts at the Central Pharmaceutical Affairs Council said the ministry could exempt a bridging trial.

​​​​The government should mandate a bridging trial for Mifegymiso, an abortion pill under the regulator’s review for marketing approval, the Korean Association of Obstetricians & Gynecologists said.
​​​​The government should mandate a bridging trial for Mifegymiso, an abortion pill under the regulator’s review for marketing approval, the Korean Association of Obstetricians & Gynecologists said.

When introducing a foreign drug that passed a phase 3 trial to Korea, researchers can obtain data for Koreans through a bridging trial. However, it is difficult to apply foreign trial results due to ethnic differences.

“To protect women’s health, we need a bridging trial of Mifegymiso,” said KSOG in a statement on Friday.

Mifegymiso is a combination drug, mixing a 200 mg mifepristone tablet with four tablets of 200ug misoprostol. It is different from Mifegyne, which contains mifepristone only.

In March, Hyundai Pharm signed an exclusive agreement with Linepharma International, a U.K.-based drugmaker, to sell Mifegymiso in Korea.

In July, the company applied for marketing approval to the MFDS.

“We do not understand why Hyundai Pharm said it would sell non-reimbursable Mifegymiso for 350,000 won ($297) with four more pills, whereas misoprostol is priced at only 150 won,” KSOG said.

The society criticized the MFDS for trying to exempt a bridging trial for the benefit of the pharmaceutical company, putting behind women’s health without verifying the safety and efficacy, and approving a new drug.

In other countries that allow abortion, women tend to use the single therapy mifepristone (Mifegyne). It is very rare to use it with misoprostol, the ob-gyn doctors’ group said.

The combination therapy lacked data significantly, and many foreign research reports say misoprostol could cause miscarriage or fetal malformations, KSOG said.

The society warned that exposure to misoprostol in the first trimester of pregnancy increased the risk of congenital disabilities approximately threefold compared to a 2 percent chance in the control group. In particular, exposure of the fetus to misoprostol may be associated with Möbius syndrome, amniotic band syndrome, and central nervous system abnormalities, KSOG said.

Physicians should inform women who were receiving misoprostol of the risk of congenital disabilities and carefully monitor the fetus exposed to the drug, it added.

If a woman fails to get pregnant after trying a medication abortion with Mifegymiso, it could be painful for both the mother and the fetus, KSOG said.

“We hope that the MFDS could make a wise decision.”

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