Drugs

REMS No Longer Needed for Amgen’s Anemia Drugs: FDA

FDA has determined that Amgen’s erythropoiesis-stimulating agents (ESAs) epoetin alfa (Procrit and Epogen) and darbepoetin alfa (Aranesp) no longer require a Risk Evaluation and Mitigation Strategy (REMS). The REMS, which was limited to the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy, is no longer necessary to ensure that therapies’ benefits outweigh their risks of shortened overall survival or increased risk of tumor progression or recurrence in patients with cancer, an agency notice says. ESAs are approved for treating anemia resulting from chronic kidney disease, chemotherapy, certain treatments for Human Immunodeficiency Virus, and also to reduce the number of blood transfusions during and after certain major surgeries.

FDA made its decision after evaluating REMS assessments submitted by Amgen and additional agency analyses intended to understand the impact of the various regulatory and other actions on the use of ESAs. FDA says the REMS assessment showed that:

Results from surveyed prescribers demonstrate acceptable knowledge of the product risks of decreased survival or the increased risk of tumor progression or recurrence and the need to counsel patients about these risks.
Drug utilization data indicates appropriate prescribing of ESAs consistent with the intended use as a treatment alternative to blood transfusions for anemia associated with myelosuppressive chemotherapy

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