Drugs

FDA OKs Bristol Myers Squibb’s Sotyktu for Psoriatic Arthritis

FDA has approved Bristol Myers Squib’s Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis. The approval expands the drug’s use beyond plaque psoriasis and introduces the first tyrosine kinase 2 (TYK2) inhibitor authorized for patients with psoriatic arthritis, a chronic autoimmune condition that causes joint inflammation and skin lesions.

The decision was based on results from two Phase 3 studies — POETYK PsA-1 and POETYK PsA-2 — which evaluated once-daily Sotyktu in adults with active disease. In both trials, significantly more patients receiving the drug achieved the primary endpoint of an ACR20 response — at least a 20% improvement in symptoms based on criteria from the American College of Rheumatology — at 16 weeks compared with those receiving placebo, according to the company.

In the POETYK PsA-1 study, 54% of patients treated with Sotyktu achieved an ACR20 response versus 34% in the placebo group. In the POETYK PsA-2 trial, 54% of patients receiving the drug met the endpoint compared with 39% of those on placebo.

The company says higher levels of clinical response were also observed. ACR50 responses were reported in 24% and 29% of Sotyktu-treated patients in the two trials, compared with 14% and 16% among placebo recipients. ACR70 responses were achieved by 12% and 10% of treated patients, compared with 5% in both placebo groups.

On the safety side, it says the safety profile observed in psoriatic arthritis patients was generally consistent with that seen in earlier trials in plaque psoriasis. The most common adverse reactions included upper respiratory infections, increased creatine phosphokinase levels, herpes simplex, mouth ulcers, folliculitis and acne. The drug label includes warnings related to infections, tuberculosis, malignancies and other risks associated with immune-modulating therapies.

The FDA originally approved Sotyktu in 2022 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome