Oral Histone Deacetylase Inhibitor Receives FDA Fast Track Designation for PV

The FDA has granted Fast Track designation to givinostat for the management of polycythemia vera (PV). Italfarmaco S.p.A., the Italy-based global pharmaceutical company developing givinostat, announced this new designation in a press release.

Givinostat is an oral histone deacetylase inhibitor designed to target abnormal gene expression in patients with PV, such as the JAK2V617F mutation. Through this mechanism, the agent is meant to control excessive cell proliferation that occurs in PV, thereby improving patients’ symptoms, disease burden, and long-term outcomes.

The agent has previously received Orphan Drug designation for use in PV from the FDA and the European Medicines Agency (EMA). A phase III study is currently enrolling patients for clinical sites in Europe, Israel, North America, and the UK, with additional sites planned.

In the release, Italfarmaco Group chief medical officer Paolo Bettica, MD, PhD, remarked that “[t]he FDA decision to grant givinostat Fast Track designation underscores the urgent need for innovative treatments for PV and highlights the potential of givinostat to make a meaningful difference. We look forward to working closely with the FDA as we plan for completion of our Phase III clinical trial.”

Reference

Italfarmaco. Accessed May 12, 2025. https://www.globenewswire.com/news-release/2025/05/06/3074789/0/en/Italfarmaco-Announces-U-S-FDA-Grants-Fast-Track-Designation-to-Givinostat-in-Treatment-of-Polycythemia-Vera.html