Incyte Says FDA Approves Jakafi in Chronic Graft-Versus-Host Disease

By Michael Dabaie

Incyte Corp. said the U.S. Food and Drug Administration approved Jakafi for treatment of chronic graft-versus-host disease in adult and pediatric patients 12 years and older.

GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, the company said.

The FDA approval was based on the REACH3 study, a Phase 3 study of Jakafi in comparison with best available therapy for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation.

"Nearly half of the people who develop chronic GVHD do not respond adequately to steroids -- the current standard of care -- making this life-threatening condition particularly challenging to treat," said Dr. Robert Zeiser of the University Medical Center Freiburg, Department of Hematology, Oncology and Stem Cell Transplantation in Freiburg, Germany, the principal investigator of the REACH3 trial.

Shares have been lower throughout Wednesday's session, recently declining 6% to $71.21.

The approval comes a day after Incyte said the FDA approved Opzelura cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older.

Opzelura safety information includes boxed warnings for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis, the company said.

"We also felt most investors (based on our recent conversations) anticipated a black box warning with general safety language around the widely debated risks of JAK inhibitors...and that's what we got," J.P. Morgan said in an analyst note.

"Our recent physician diligence suggests docs were excited about this potential new treatment option, and we expect this to be a closely monitored launch. Bigger picture, this marks yet another approval for INCY as the company attempts to diversify away from a prevailing over-reliance on Jakafi," J.P. Morgan said in its note.

Keeping in-line with a more conservative outlook toward Janus kinase, or JAK, inhibitors, the FDA approved Opzelura with the warning that was similar to the oral JAKs issued recently, Truist Securities noted. "While this is not in-line with our expectations, we believe that the drug is likely to be used despite the warning based on - 1) robust data; 2) positive [key opinion leader] feedback; 3) unmet need; and 4) first to market advantage with topical competitors still in Phase 3 trials," Truist said.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

September 22, 2021 13:41 ET (17:41 GMT)

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