Risankizumab

UCB announces BE BOLD, a Phase 3b study comparing BIMZELX® (bimekizumab) with SKYRIZI® (risankizumab) in treating active psoriatic arthritis (PsA), marking the first head-to-head study in PsA evaluating an IL-17A and IL-17F inhibitor versus an IL-23 inhibitor. The primary endpoint is ACR50 at Week 16, aiming to provide meaningful comparison on inflamed joints. Top-line results expected in 2026.

After a July surge in FDA approvals for gastroenterology, including the first blood test for colorectal cancer, the agency saw a summer lull with only three GI approvals. Notable approvals included Skyrizi for UC and Crohn’s, a rapid HCV test for point-of-care use, and a third ustekinumab biosimilar.

FDA approves Johnson & Johnson's Tremfya for ulcerative colitis, adding to its existing approvals for plaque psoriasis and psoriatic arthritis. Tremfya's potential to generate $5B in revenue is significant, especially as J&J's Stelara faces market exclusivity loss and price cuts. Competitors like AbbVie and Eli Lilly also have strong IBD treatments, intensifying the market competition.

The FDA approves Johnson & Johnson's Tremfya, an IL-23 inhibitor, for treating moderately to severely active ulcerative colitis, marking its third indication. Tremfya competes with AbbVie's Skyrizi in the UC market. The approval is based on the QUASAR trial, showing 50% of patients achieved clinical remission with Tremfya 200 mg every 4 weeks.

Amgen Inc., a biopharmaceutical company, saw its share price rise due to the $27.8 billion acquisition of Horizon Therapeutics and strong demand for its drugs. Despite raising its 2023 revenue guidance, Amgen faces risks from declining sales of immunology products, high debt, and upcoming competition from Prolia biosimilars. The company's valuation remains unattractive, with a 'market perform' rating advised.

Nature Reviews Drug Discovery forecasts the top 10 pharmaceutical products for 2024, each expected to surpass $10 billion in sales. Leading the list is Keytruda by Merck & Co., with a projected $27.19 billion in sales, followed by Ozempic, Dupixent, Eliquis, Biktarvy, Darzalex, Opdivo, Comirnaty, Gardasil, and Skyrizi. These drugs cover a range of treatments from cancer to diabetes, HIV, and COVID-19, highlighting significant advancements and market potentials in the pharmaceutical industry.