Bijuva: a new combination HRT

Approval of a "new" hrt made some press headlines for Bijuva. There is not yet a label available (update: see below) from the FDA, but the Reuters press release describes it as
an oral softgel capsule containing a combination of artificial hormones chemically identical to human female sex hormones estradiol and progesterone.

Other press sources are calling it things like "the first and only FDA-approved bio-identical* hormone therapy," which is perhaps stretching things just a bit by implication. It seems to be simply human-identical estradiol and human-identical progesterone in one pill, with the dose it contains identified in releases as 1 mg/100 mg. The "artificial hormones" aspect is simply an overly precise way of stating that they are produced in the laboratory, as is the case with all human-identical hrts, instead of being refined from animal sources, as Premarin is, to produce synthetic or non-human-identical hormonal agents.

So that means that this new pill (which could be expensive because it's new) contains the same things as a generic Estrace 1 mg, one of the cheapest hrts around, plus a 100 mg capsule of Prometrium, also an older formulation. The "new" about this is simply the combination, not actually the fact that FDA-approved human-identical hrts are available in oral dose form.

It's also worth noting that the name, Bijuva, is quite similar in sound to the now-discontinued hrt, Enjuvia. Bijuva is not a replacement for Enjuvia: it contains entirely different hormonal formulations.

So is this a real improvement? If this is the precise dose that any given woman needs and if she finds that the convenience of taking one pill rather than two is worth paying for, then yes, it might be. If her insurance company cuts a deal with the manufacturer or supplier such that they can beat the price of that same supplier for the two separate hrts, she may not have a choice. But for a woman who is in the early stages of working out her needs or who hopes to customize her dose, it could be less suitable because she is locked into just those two doses.

Unlike progesterone-only gelcaps which can be used vaginally, this hrt would not be suitable for vaginal use because of the high dose of estrogen it contains (read more about why taking systemic doses of the active estrogen via pelvic circulation delivery is not necessarily the best idea ever).

And, like all oral hrts, it would provide delivery-related effects that may not be the best option for some women.

The press releases suggest that this new formulation will come on the market in late 2019. We'll keep an eye out and update this and our combination hrts listing page once the FDA releases the full packaging information for it.  

Update: Here's the full FDA product sheet for Bijuva.