ABBVIE

Johnson & Johnson seeks FDA approval for subcutaneous Tremfya injections for ulcerative colitis, potentially offering an alternative to current IV infusions, based on Phase III ASTRO study results.

Merck's subcutaneous Keytruda, combined with chemotherapy, proved as effective as the IV version in a late-stage trial, crucial as patent protection nears expiration. Keytruda's $25 billion in sales last year made it the bestselling drug, representing over 41% of Merck's total sales. Competition heats up with Roche's subcutaneous Tecentriq Hybreza and Bristol Myers Squibb's potential subcutaneous Opdivo. Merck's shares rose 2% following the subcutaneous data release.

KarXT, a new schizophrenia drug targeting muscarinic receptors, has sparked excitement in psychiatric medicine, with several similar drugs in development. However, the failure of a highly anticipated muscarinic drug, emraclidine, in a trial raises questions about the future of this approach. KarXT's success has revived interest in muscarinic drugs, but the development process remains challenging and uncertain.

The hidradenitis suppurativa market is projected to grow at a CAGR of 12.4% by 2034, driven by increased awareness, treatment access, biologic therapy approvals, and a robust pipeline. The market size in the 7MM was USD 1.4 billion in 2023, with approximately 6.2 million prevalent cases. Key companies and treatments include Incyte Corporation, AbbVie, MoonLake Immunotherapeutics, and therapies like Povorcitinib, RINVOQ, Lutikizumab, and Sonelokimab. Regulatory milestones and clinical trials are advancing, with potential market shifts expected from emerging therapies.

FDA approves Bimzelx, the first interleukin-17F and -17A inhibitor, for moderate to severe hidradenitis suppurativa in adults, based on BE HEARD trials results.

The Biosecure Act, aimed at limiting U.S. companies' ties with Chinese biotechs, gains momentum under Trump, though its Senate passage remains uncertain. U.S. biopharmas face a costly shift away from Chinese partners, with a 2032 deadline, amid broader U.S.-China tensions.

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Jochen Salfeld, AbbVie's VP of virology, discusses the evolving concept of 'cure' in medicine, emphasizing the need for innovative thinking and technology integration. AbbVie is exploring curative potential in HIV through a combination therapy involving two antibodies, aiming for a disease-free state without continuous treatment. Salfeld highlights the importance of cross-functional collaboration and the use of AI and machine learning in R&D, drawing parallels to AbbVie's successful hepatitis C cure, Mavyret.

The FDA accepted Aldeyra Therapeutics' resubmitted NDA for topical reproxalap, a first-in-class candidate for dry eye disease. Aldeyra expanded its option agreement with AbbVie, receiving $100 million upfront and potential $300 million in milestone payments. The NDA includes positive Phase 3 trial results, and the PDUFA date is set for April 2, 2025.

Johnson & Johnson's once-daily oral IL-23 inhibitor icotrokinra met efficacy objectives in phase 3 ICONIC-LEAD trial for moderate to severe plaque psoriasis, with 74.1% achieving clear or almost clear skin at week 24. The drug showed similar safety profiles to placebo and could offer a patient-friendly alternative to injectable biologics. J&J plans to submit data to regulators and compete with Bristol-Myers Squibb's TYK2 inhibitor Sotyktu.