The approval of rusfertide—now to be branded Mimrylo—for polycythemia vera marks a key win for Takeda, which now has crossed the FDA finish line for two of three critical product launches slated for the coming year.
The FDA has signed off on Takeda and Protagonist Therapeutics’ peptide therapeutic rusfertide for the treatment of patients with polycythemia vera, a rare malignancy of the blood. The drug will be sold as Mimrylo and could reach peak sales of $2 billion, according to Jefferies analysts.
The news follows an FDA greenlight earlier this month for Takeda’s narcolepsy medicine Orzeyful, the first orexin receptor 2 agonist to hit the market. Together these approvals “mark the first two major launches in Takeda’s next growth cycle,” Jefferies wrote to investors in a Sunday morning note.
Mimrylo is the first hepcidin mimetic designed to regulate the overproduction of red blood cells and the distribution of iron throughout the body to control hematocrit levels—a measure of how much of the blood is made up of red blood cells—according to Takeda’s news release on Friday. In polycythemia vera (PV), hematocrit is ideally kept under 45% to lower the risk of blood clots.
The FDA’s verdict on Friday was backed by data from the Phase 3 VERIFY study, which found that patients on Mimrylo plus standard of care achieved significantly greater response rate than placebo plus standard of care, lowering patients’ need for phlebotomies.
Mimrylo was originally developed by California biotech Protagonist. In 2024, Takeda paid $300 million upfront to co-develop and co-commercialize the drug globally.
The drug, given weekly as an under-the-skin injection, has a “broader than expected label” that doesn’t require patients to have undergone prior treatment with medications that lower blood cell counts, according to Jefferies. This far-reaching label could, in turn, support faster uptake, added the firm, which forecast peak sales of $2 billion.
Jefferies also adopted an optimistic outlook for the pharma’s third growth pillar. “We expect [an approval for] Zasocitinib for psoriasis to follow” in the first half of the calendar year 2027, Jefferies said.
Phase 3 data released earlier this year showed that Takeda’s pill elicited complete skin clearance in more than 35% of treated patients at 16 weeks—an effect that was “more than 2.5 times the response rate” for Bristol Myers Squibb’s Sotyktu, the Japanese pharma claimed at the time. Takeda is eyeing a new drug application (NDA) for zasocitinib later this year, with a potential launch early next year, according to an announcement last month.
Successfully delivering these three launches is a top priority for Takeda, CEO Julie Kim said during the company’s annual shareholder meeting in June, calling 2026 a “year of transition.” Kim recently stepped on as CEO, succeeding Christophe Weber, who helmed Takeda for 12 years.
