Drugs

FDA Approves Janssen’s Stelara for Crohn’s

FDA has approved a Janssen Biotech BLA for Stelara (ustekinumab) for treating moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor blocker, or who failed or were intolerant to treatment with one or more TNF blockers. The therapy works by targeting interleukin (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses, according to the company.

Approval was based on data from a Phase 3 study called UNITI, which showed ustekinumab inducing a clinical response and clinical remission in Crohn’s patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-tumor necrosis factor-alpha therapy, Janssen says. “Major secondary endpoints of clinical response and clinical remission at week 8 were also significantly higher among patients receiving Stelara compared with patients receiving placebo,” it adds.

Stelara is currently FDA-approved for treating adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. It is also approved for treating adult patients with active psoriatic arthritis and can be used alone or in combination with methotrexate.

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