Aviva Bio’s AVA-291 Emerges as Best-in-Class Therapy to Address FDA-Identified Safety Concerns of Testosterone for Women
Aviva Bio, a biotechnology company developing next-generation hormone therapies, highlighted the importance of advancing testosterone therapies designed for women following the FDA's September 17 public workshop, “Testosterone Use in Menopausal Women.”
Aviva Bio Announces FDA Guidance on Development Pathway for Women’s Testosterone Therapy and New Evidence of a Reduced Risk of Breast Cancer Cell Proliferation for AVA-291
Aviva Bio, a new biotechnology company focused on rewriting the narrative around hormone-based medicine, announced today it has received formal feedback from the FDA in a Type B meeting regarding the requirements for the development of a testosterone (T) therapy for women. AVA-291 (d3-T) is a next-generation testosterone designed to retain T’s androgen activity while resisting aromatization. The aromatization of T locally in breast tissue is linked to an increased risk of breast cancer.1,2,3 Today’s announcement marks an important milestone in advancing testosterone therapy for women, a patient population with significant unmet need that has been long constrained by safety concerns and the absence of an FDA-approved, female-specific therapy.
