Hormone therapy for menopausal symptomsJune 11, 2019
The US FDA has approved first of its kind capsule Bijuva which contains progesterone and estradiol, announced TherapeuticMD.
It is the first bio-identical hormone therapy combination that has been approved by the FDA.
The approval is based on the Bijuva clinical development programme that included the pivotal phase III Replenish Trial. This trial evaluated the safety and efficacy of Bijuva in generally healthy, postmenopausal women with a uterus for the treatment of moderate to severe hot flashes.
The co-primary efficacy endpoints in the Replenish Trial were the change from baseline in the number and severity of hot flashes at weeks 4 and 12 as compared to placebo.
Bijuva demonstrated a statistically significant reduction from baseline in both the frequency and severity of hot flashes compared to placebo while reducing the risks to the endometrium. The results of the trial were published in the journal Obstetrics & Gynecology.