FDA approves added indication for Jakafi

The US Food and Drug Administration has approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. Marketed in the USA by biotech firm Incyte (Nasdaq: INCY), Jakafi is the first and only FDA-approved treatment for this indication, the company announced on May 24.

“For the first time, patients with steroid-refractory acute GVHD, and the physicians that treat them, have an FDA-approved treatment for this serious disease,” stated Hervé Hoppenot, chief executive of Incyte, adding: “This approval is also an important milestone for Incyte, as it marks the third indication for Jakafi in the United States, further underscoring Incyte’s commitment to delivering innovative medicines for patients in need. We are proud of the impact Jakafi has had on patients’ lives to-date and are dedicated to advancing our ongoing research in JAK inhibition to serve more GVHD patients in the future.”

The approval should relieve the investors as the FDA had earlier extended the review period of the supplemental New Drug Application. However, market reaction was mooted, as the stock gained just 1.55% to $81.75 on Friday, ahead of the holiday weekend in the USA.