Shots:
- The US FDA has accepted the sNDA of Miudella (hormone-free copper intrauterine system) for an extended duration of use for up to 6yrs. with the PDUFA action date expected in Q2’27
- Miudella was evaluated in 3 trials across US in 1904 women (17-45yrs.), where the efficacy cohort (17-35yrs.) of the P-III trial (n=1397) showed 99% effectiveness, with a 1yr. Pearl Index of 0.94 & a cumulative 3yr. Pearl Index of 1.05, plus ~99% placement success rate
- In Jun 2026, Sebela granted Organon exclusive global rights to Miudella, which was previously approved by the FDA for the prevention of pregnancy in females of reproductive potential for ~3yrs. & is expected to be commercially available in late 2026
Ref: Businesswire | Image: Organon | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
