Amid fierce competition in hemophilia, Bayer scores FDA nod for its long-acting drug Jivi

Bayer
Bayer won FDA approval for a new hemophilia A treatment, Jivi, on Thursday. (Bayer)

Bayer just scored an FDA nod for its long-acting hemophilia treatment Jivi, a next-gen follow-up to its older blockbusters. That's the good news. The not so good: The drug will have to square off against a cadre of other next-gen drugs.

And Bayer knows it. The German drugmaker is already positioning Jivi, a factor VIII replacement therapy, for that competition, touting its variable dosing as a selling point against its rivals. The drug essentially gives patients and doctors more options when using it to prevent bleeding, Bayer’s Aleksandra Vlajnic, VP of U.S. medical affairs, said in an interview. While initially dosed twice a week, Jivi can then be dosed more or less frequently as needed.

When it's launched in the U.S. next week, the drug will face competition from Shire and Sanofi, which just completed its $11.9 billion buyout of hemophilia-focused Bioverativ. Also lurking is Roche, which last year scored approval for its antibody-based treatment Hemlibra in patients who've developed factor VIII inhibitors after using replacement therapies. Analysts believe the drug will pull in $2 billion by 2025, and the drug recently nabbed a breakthrough designation for a new approval in patients without those inhibitors.

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RELATED: Roche's Hemlibra, eyeing a big new market, puts up standard-busting bleed data

In Bayer's approval announcement, Jivi's lead investigator Dr. Mark Reding also highlighted the drug's flexibility. The drug will be a “welcome option that addresses a growing patient need to integrate treatment with personal lifestyles,” Reding said.

Jivi's approval was based on a 126-patient phase 2/3 trial that tested prophylactic dosing, on-demand treatment for bleeding and management of bleeding in surgery patients

Bayer has been developing the drug since 2007, the company's director of late phase project and outsourcing John Teare told FiercePharma. Jivi entered phase 1 and 2010 and moved into its phase 2/3 combo study in 2011. Bayer started working on Jivi and Kovaltry at about the same time, but Kovaltry made it to the market faster. That hemophilia A drug launched in 2016, and together with the older drug Kogenate, brought in about $1 billion last year.

Aside from its marketed drugs, Bayer has partnered with Ultragenyx on a factor VIII gene therapy program and is gearing up for phase 1 studies. Gene therapies could one day cure patients' disease, rather than required routine dosing to prevent bleeding. The company has other research programs underway in hemophilia, as well. Bayer launched its first recombinant factor VIII drug Kogenate in 1993.

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