Drugs

AstraZeneca Pulling Andexxa From Market Due to Safety

A newly issued safety update from FDA concludes that the risks associated with AstraZeneca’s Andexxa now outweigh its clinical benefits and calls on the company to withdraw the drug from the U.S. market by the end of the month. Andexxa was granted accelerated approval in 2018 as a reversal agent for the anticoagulants rivaroxaban and apixaban in patients experiencing life-threatening or uncontrolled bleeding. Approval was based on a surrogate laboratory endpoint — reductions in anti–factor Xa activity — and included a Boxed Warning for thromboembolic risks.

The agency’s safety communication says postmarketing data show increased rates of serious and sometimes fatal thromboembolic events in patients treated with Andexxa. In reaction to the information, AstraZeneca has requested to voluntarily withdraw Andexxa’s BLA for commercial reasons and confirmed it will end U.S. commercial sales by 12/22.

As a condition of accelerated approval, AstraZeneca was required to conduct a randomized controlled trial to confirm clinical benefit. Results from the confirmatory ANNEXA-I study, submitted to the FDA in 1/2024, raised significant safety concerns. The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee reviewed the data in 11/2024.

According to FDA, the trial showed higher rates of thrombosis and thrombosis-related deaths in patients treated with Andexxa compared with standard care. Thrombotic events occurred in 14.6% of patients in the Andexxa arm versus 6.9% in the control group, while thrombosis-related deaths at 30 days were 2.5% with Andexxa compared with 0.9% with standard care, it says. More than half of thrombotic events in the Andexxa group occurred earlier than those seen in the control arm.

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

Read more

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