A New PV Treatment in Clinical Trials: Rusfertide

Learn how a new polycythemia vera (PV) treatment in clinical trials called rusfertide is showing promise in helping patients reduce the number of blood draws they need each year to manage the cancer. 

What is Rusfertide for PV? 

Rusfertide is a new medicine for people with polycythemia vera (PV) being evaluated in a phase 3 clinical trial called the VERIFY study. The trial is active, but it is no longer recruiting.  

Phase 3 refers to comparing the new treatment to standard PV therapy. To learn about how clinical trials work in general, click here. 

Rusfertide is administered as an injection. It works by mimicking the hepcidin hormone, which regulates how your body uses iron. Iron is important for a lot of the cellular processes in the body. Treatment with rusfertide tricks the body into believing it has higher blood levels, which causes iron levels to drop in the bloodstream. Then, the production of red blood cells decreases.

This supports PV patients in reducing the number of blood draws (phlebotomy) they need and maintaining healthy blood levels. Blood draws are often needed for PV patients because the cancer affects an overproduction of red blood cells. Click the following link to read more about “What is Polycythemia Vera?” 

As a person with PV, decreasing the number of blood draws you receive can help reduce side effects associated with blood draws, like fatigue, brain fog, and traveling to visit a doctor. 

How Effective is Rusfertide for PV?

Data from phase 2 of the REVIVE study showed for 70 PV patients who took rusfertide in addition to their ongoing treatment:

• The majority of patients experienced a significant reduction in the number of blood draws required. Most patients went from 9 blood draws a year to only 1 blood draw a year.
• Patients were supported in maintaining healthy red blood cell levels (hematocrit)  without a blood draw for more than two years.
• PV-related symptoms like fatigue, night sweats, brain fog, and itching decreased.
• The most common side effect experienced was an injection site reaction of itching and swelling. These cases were usually mild and decreased over time. 

The pharmaceutical companies Protagonist, in collaboration with Takeda, plan to submit rusfertide’s FDA approval application in 2025. 

Summary 

Rusfertide is a promising polycythemia vera treatment in a phase 3 clinical trial. Data from the REVIVE study testing rusfertide showed that it helped the majority of PV patients greatly reduce the number of blood draws needed each year, decreased PV-related symptoms, and helped improve red blood cell levels. It is hoped that the medicine will become FDA-approved in 2025. 

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Sources: 

• Rusfertide Nearly Eliminates Need for Phlebotomies to Treat Polycythemia Vera
• Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)
• Takeda and Protagonist Therapeutics, Inc. Enter into Worldwide License and Collaboration Agreement for Rusfertide, a Late-Stage Rare Hematology Asset