Organon Says 6-Year Miudella Data Supports FDA Application for Extended Use

MT Newswires Live10-16

Organon (OGN) said Friday that interim results from a phase 3 trial of hormone-free copper intrauterine device Miudella support its supplemental new drug application for an extended duration of use through six years.

The company said the data from Sebela Women's Health showed a cumulative six-year Pearl Index of 0.93 and a Kaplan-Meier pregnancy rate of 3.9%.

No new safety signals observed during the additional three years of use, according to Organon.

The US Food and Drug Administration has accepted Organon's application to extend Miudella's approved duration of use from to six years from three years, with a decision expected in Q2 of 2027, the company said.

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