UK approves J&J's oral psoriasis pill
Oct 23 (Reuters) - 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