FDA Breakthrough designation for Incyte's Jakafi in acute GVHD

The US Food and Drug Administration has granted Breakthrough Therapy designation for US biotech firm Incyte’s (Nasdaq: INCY) Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host disease (GVHD).

Shares of Incyte were up nearly 3% at $80.90 in pre-market trading this morning following the announcement. There are currently no approved treatments for patients with acute GVHD.

“Receiving Breakthrough Therapy Designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to-date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, Incyte’s chief medical officer, adding: “We are committed to working closely with the FDA in an effort to bring ruxolitinib to patients with GVHD as soon as possible.”