Biogen’s Omaveloxolone Study: Assessing Safety During Pregnancy and Lactation

Biogen Inc. ((BIIB)) announced an update on their ongoing clinical study.

Biogen Inc. is conducting a study titled A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications, and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation. The study aims to evaluate the safety of BIIB141 (Omaveloxolone) for individuals with Friedrich’s Ataxia who took the drug during pregnancy and/or breastfeeding, focusing on potential birth defects and maternal health complications.

The intervention being tested is the drug Omaveloxolone, which is intended to treat Friedrich’s Ataxia. The study seeks to understand its effects when taken during pregnancy and lactation.

This observational study follows a cohort model with a prospective time perspective. Participants’ health information is collected without altering their medical care, aiming to assess the drug’s impact on pregnancy and infant health.

The study began on September 30, 2024, with the last update submitted on June 23, 2025. It is currently recruiting participants and is expected to last at least 10 years, with each participant involved for up to one year post-birth.

The update on this study could influence Biogen’s stock performance by providing insights into the safety profile of Omaveloxolone, potentially affecting investor sentiment. It also positions Biogen in the competitive landscape of treatments for Friedrich’s Ataxia.

The study is ongoing, and further details are available on the ClinicalTrials portal.