UK approves J&J's oral psoriasis pill

By Reuters News

- Britain's medicines regulator on Friday approved Johnson & Johnson's JNJ.N daily pill for adults and teenagers with moderate-to-severe plaque psoriasis, a skin condition causing red, scaly and often itchy or painful patches.


Here are some details:

  • 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 US earlier this year for the same condition — its first approved indication

  • The drug is made in collaboration with Protagonist Therapeutics PTGX.O

  • 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 BMY.N Sotyktu and AbbVie's blockbuster ABBV.N Skyrizi

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