Based on results from the Phase 2/3 PROTECT VIII trial, the US Food and Drug Administration (FDA) has approved Bayer’s Jivi for routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older.

The drug is a Factor VIII replacement therapy, meaning it replaces the patient’s reduced or missing FVIII and as the third FDA-approved hemophilia A treatment in Bayer’s portfolio is a follow-up for the German group’s older blockbusters such as the recombinant Factor VIII drug Kogenate launched in 1993.

Simultaneously, the FDA approved Jivi for on-demand treatment and the perioperative management of bleeding in the same population. Bayer has submitted marketing authorization applications for the medication in the EU and Japan.

When officially launched in the US next week, Jivi will face competition from drugs made by Netherlands-based Shire, which is being acquired by Japan’s Takeda, as well as from France’s Sanofi, which recently completed the acquisition of Bioverativ.  Roche last year received approval for its antibody-based treatment Hemlibra in patients who developed Factor VIII inhibitors after using replacement therapies.

Analysts quoted by the US pharmaceutical trade journal Fierce Pharma said they believe Jivi could rack up sales of more than $2 billion by 2025.

Bayer touts Jivi’s variable dosing as a selling point against its rivals. Initially dosed twice a week, it can subsequently be dosed more or less frequently as needed. In announcing the FDA approval, the group quoted the trial’s lead investigator, physician Mark Reding, as saying the drug will addresses a growing patient need to integrate treatment with personal lifestyles.

The 126-patient phase 2/3 trial that led to Jivi’s approval tested prophylactic dosing, on-demand treatment for bleeding and management of bleeding in surgery patients. Bayer has been developing the drug since 2007, completing the phase 2/ 3 combo study in 2011 but launching another hemophilia product, Kovaltry, ahead of it.

As well as researching other hemophilia treatments, Bayer is partnering with Ultragenyx on a factor VIII gene therapy program. The drugmaker also has other hemophilia research programs in progress.