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
"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
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 firstname.lastname@example.org
(END) Dow Jones Newswires
September 22, 2021 13:41 ET (17:41 GMT)
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