FDA Approves Copper IUD, MIUDELLA®

The U.S. Food and Drug Administration (FDA) has approved MIUDELLA®, a hormone-free copper intrauterine system (IUS) from Sebela Women's Health Inc. This marks the first approval of its kind in over 40 years. MIUDELLA® is designed to prevent pregnancy for up to three years and features a flexible nitinol frame with a reduced copper dose, making it a next-generation, low-dose option. Clinical trials demonstrated MIUDELLA®'s safety, efficacy, and tolerability, with low expulsion and discontinuation rates. It comes preloaded in a small, flexible frame, which simplifies insertion. “Our innovative copper IUD MIUDELLA® offers effective pregnancy prevention using less than half the copper of the currently available copper-based IUD in the U.S., utilizing a small, flexible nitinol frame. We believe these and other features of MIUDELLA may help address barriers to use, while also providing women with the hormone-free option some prefer,” said Kelly Culwell, MD, Head of Research and Development, Sebela Women’s Health. Read more here.