Drugs

AstraZeneca’s Voydeya OK’d for Hemolysis

FDA has approved AstraZeneca’s Voydeya (danicopan) as an add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab) for treating extravascular hemolysis (EVH) ) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Danicopan is described as a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care to help the 10-20% of patients with PNH who experience clinically significant EVH while treated with a C5 inhibitor.

Approval was based on data from the pivotal ALPHA Phase 3 trial. Results showed that Voydeya “met the primary endpoint of change in hemoglobin from baseline to week 12 and all key secondary endpoints, including transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) score,” the company says.

Additionally, data from the ALPHA trial showed Voydeya was generally well tolerated, and no new safety concerns were identified. “In the trial, the most common treatment-emergent adverse events were headache, nausea, arthralgia and diarrhoea,” 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