Drugs

FDA Approval Expands Label for Novartis’ Promacta

FDA has approved an expanded label for Novartis’ Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with severe aplastic anemia (SAA) in combination with standard immunosuppressive therapy (IST). The oral thrombopoietin receptor agonist is currently approved for SAA for patients who have had an insufficient response to IST. It is also approved for adults and children with chronic immune thrombocytopenia who are refractory to other treatments, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus infection.

Approval is based on Novartis’ analysis of research sponsored by the National Heart, Lung and Blood Institute and conducted under a Cooperative Research and Development Agreement. According to the company, data showed that 44% of definitive IST-naive SAA patients achieved complete response at six months when treated with Promacta concurrently with standard IST, which was 27% higher than the complete response rate historically observed with the standard IST alone. The overall response rate was 79% at six months.

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