TherapeuticsMD just racked up its third FDA approval of the year, this time for a menopause remedy that combines two bioidentical hormones.
The agency cleared Bijuva, an oral softgel that contains estradiol and progesterone, two commonly used hormone therapies, to alleviate menopause symptoms such as hot flashes. TherapeuticsMD's ingredients are artificially produced but chemically identical to hormones made naturally by women's bodies.
As the women’s health-focused company’s third FDA nod this year—following Imvexxy, a bioidentical estradiol vaginal insert, and Annovera, a hormonal birth control ring—Bijuva will roll out in the second quarter of 2019. The company said the target date allows it to build up the foundation for its launch.
“We will expand our salesforce in Q1 to cover the more significant market opportunity for Bijuva, as well as activate payer discussions to ensure coverage ramp is in line with our expectations,” a spokesperson told FiercePharma via email.
The company hasn't yet set a price, but it expects “to price at parity to the other drugs in the market despite the other compounds being older drugs,” the spokesperson said.
Bijuva is the first bioidentical combo hormone therapy the FDA has approved, the company said. The agency has greenlighted separate estradiol and progesterone pills that are bioidentical, but not intended to be used together. Synthetic versions of that combo are available, however, and some compounded bioidentical hormones are circulating on the market, TherapeuticsMD said.
Although there’s currently no evidence showing bioidentical therapies are better than synthetic hormones, the Florida company thinks there’s still a meaningful market up for grabs.
Citing data from IQVIA and a consensus estimate from Symphony Health Solutions, TherapeuticsMD figures that the separate bioidentical drugs, plus the compounded versions, together account for 15 million to 20 million dispensed prescriptions each year in the U.S. These are the easier targets because Bijuva can save patients out-of-pocket costs via insurance coverage and can eliminate risks of compounded hormone therapy, the company argues.
“Bijuva addresses a significant demand for bioidentical hormone therapy and provides women, their healthcare providers and pharmacists with a proven bi-identical combination product that can be covered by their insurance,” said company CEO Robert Finizio in a statement.
As the first phase of its launch plan, the company started an outreach program called Bio-Ignite. The aim is to reach some 3,000 high-volume compounding pharmacies to garner their interest in replacing their compounded bioidentical estradiol and progesterone with Bijuva.