Drugs

FDA Approves Celgene’s Reblozyl for Some Anemic Adults

FDA has approved Celgene’s Reblozyl (luspatercept-aamt), the first therapy to treat anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. An agency notice says that beta thalassemia (Cooley’s anemia) is an inherited blood disorder that reduces the production of hemoglobin. In people with beta thalassemia, low hemoglobin levels can lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue, and more serious complications, FDA says.

The notice says approval of Reblozyl was based on results of a clinical trial of 330 patients with beta thalassemia who required red blood cell transfusions. Some 21% of the patients who received Reblozyl achieved at least a 33% reduction in transfusions, compared to 4.5% of patients receiving a placebo.

Common side effects associated with Reblozyl were headache, bone pain, arthralgia, fatigue, cough, abdominal pain, diarrhea, and dizziness.

FDA granted the Reblozyl application a fast track designation and an orphan drug designation.

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