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Us Fda Approves J&j's Oral Psoriasis Pill
FDA approved Icotyde, the first oral IL-23-targeted pill for moderate-to-severe plaque psoriasis, showing 65% of patients achieved 90% skin clearance in trials.
- On Wednesday, the U.S. Food and Drug Administration approved Icotyde, Johnson & Johnson's oral pill for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older who weigh at least 88 pounds.
- Developed as icotrokinra, Icotyde was designed to mirror injectables like Skyrizi and Tremfya without needles, addressing patients who often avoid injections after topicals; Johnson & Johnson licensed it from Protagonist Therapeutics in 2017 in a deal worth up to $1 billion.
- ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD showed about two-thirds of treated patients achieved at least 90% skin clearance versus about 40%, with 15-20% IGA differences, Linda Stein Gold said.
- J&J projects more than $5 billion in peak sales for Icotyde, triggering a $50 million milestone payment to Protagonist, while shares of J&J slid 0.25% Wednesday and AbbVie fell over 4%.
- Johnson & Johnson is already testing Icotyde in psoriatic arthritis, ulcerative colitis and Crohn's disease, with Jennifer Taubert calling it "revolutionary" for patients and clinicians.
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Johnson & Johnson-Protagonist Therapeutics Partnered New Psoriasis Pill Wins FDA Nod, Shakes Up Competition With AbbVie - Johnson & Johnson (NYSE:JNJ), Protagonist Therapeutics (NASDAQ:PTGX)
On Wednesday, the U.S. Food and Drug Administration (FDA) approved Icotyde (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older. FDA Approves Icotyde for Plaque Psoriasis in Adults and Teens Icotyde was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. (NASDA…
·New York, United States
Read Full Article'Potential Game Changer' for Psoriasis Gets Green Light From FDA
(MedPage Today) -- The FDA has approved the first oral interleukin (IL)-23-targeted therapy for plaque psoriasis, Johnson & Johnson announced. The approval of icotrokinra (Icotyde) stipulates use in adults and children 12 or older with moderate...
·New York, United States
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