UK approves J&J's oral psoriasis pill left The approval was based on four late-stage trials in 2,500 people with the disease, including 72 teenagers aged 12 to under 18 |Image used for representational purpose only Getty Images Getty Images https://th-i.thgim.com/public/incoming/x8jdvd/article71630859.ece/alternates/FREE_1200/IMG_iStock-1321166314.jp_2_1_57C0BDGM.jpg Jacques Hugo The hands of a man with psoriatic arthritis on a wooden table, showing deformities in the fingers.
In all four studies, patients who took the drug saw better results after 16 weeks than those given a placebo, the regulator said Oct 23 (Reuters) - Britain’s medicines regulator on Friday approved Johnson & Johnson’s daily pill for adults and teenagers with moderate-to-severe plaque psoriasis, a skin condition causing red, scaly and often itchy or painful patches.
The Medicines and Healthcare Products Regulatory Agency (MHRA) approved the oral drug Icotyde for people aged 12 and older who weigh at least 40 kg.
The approval was based on four late-stage trials in 2,500 people with the disease, including 72 teenagers aged 12 to under 18.
In all four studies, patients who took the drug saw better results after 16 weeks than those given a placebo, the regulator said.
Icotyde was approved in the U.
S. earlier this year for the same condition — its first approved indication.
The drug is made in collaboration with Protagonist Therapeutics.
J&J is also studying the drug, chemically known as icotrokinra, for ulcerative colitis, psoriatic arthritis and Crohn’s disease.
The company expects the treatment to bring in $5 billion in peak sales across multiple indications.
The drug competes with established psoriasis treatments such as Bristol Myers Squibb’s Sotyktu and AbbVie’s blockbuster Skyrizi. (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore)
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