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MSD Korea fails to submit PMS data, gets Elonva approval canceled

Marian Chu  Published 2018.07.03  16:11  Updated 2018.07.03 16:17

공유
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The Ministry of Food and Drug Safety Thursday canceled the approval for MSD Korea’s ovarian stimulation injection Elonva (Corifollitropin Alfa) used to help women undergoing infertility treatment get pregnant.

Elonva Injection

The cancellation applies to both the 100㎍ and 500㎍ doses of the injection.

The ministry had confirmed an insufficient number of subjects in the post-marketing surveillance (PMS) data MSD Korea submitted while re-evaluating its application and requested supplementary data, but the firm did not.

New drugs are subject to a mandatory six-year review while incrementally modified drugs are subject to a four-year review for gathering data on safety and efficacy.

After these periods, the ministry tells drugmakers to submit the data for review within three months. If the firms fail to do so, the ministry suspends their sales for three months. If they fail for the second time, it suspends sales for six months. If they fail for the third time, it cancels their approvals.

The rules also apply when there aren’t enough clinical subjects for gathering the data.

MSD Korea’s Elonva got canceled, as the company failed to submit the supplementary data repeatedly.

The therapy won the approval in 2011 for inducing controlled ovarian stimulation in combination with gonadotropin-releasing hormone (GnRH) antagonists for women receiving assisted reproductive technology (ART).

As the first continual follicle stimulating agent, the once-weekly injection fosters the growth of a large number of follicles proving to be more convenient than administering follicle stimulating hormones every day for seven days.

yjc@docdocdoc.co.kr

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