Drugs

Takeda’s Entyvio OK’d for Crohn’s Maintenance

FDA has approved Takeda’s Entyvio (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease after induction therapy with intravenous Entyvio. Approval is based on data from the VISIBLE 2 Study, a Phase 3, placebo-controlled trial. “In VISIBLE 2, about half of patients treated with ENTYVIO SC achieved long-term clinical remission,” a company release says.

Takeda says that in the trial a “statistically significant proportion of patients receiving Entyvio SC 108 mg maintenance therapy administered every two weeks achieved long-term clinical remission compared to patients receiving placebo (48% vs. 34%; p<0.01) at Week 52.” On the safety side, Entyvio SC’s safety profile was generally consistent with the known safety profile of intravenous Entyvio. The most common adverse reactions reported were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities, it says.

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