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.
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
• 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)
