Drugs

Panel Input Sought on Andexxa’s Thrombosis Risk

FDA is seeking input 11/21 from its Cellular, Tissue, and Gene Therapies Advisory Committee about AstraZeneca’s Andexxa (coagulation factor Xa recombinant, inactivated-zhzo) and an increased risk of thrombosis relative to the therapy’s benefits. The therapy was granted accelerated approval in 2018 for patients treated with blood thinners rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The discussion was prompted by a supplemental BLA that included confirmatory data (ANNEXA-I trial) to convert the therapy’s accelerated approval to full approval. Data from ANNEXA-I showed that while andexanet demonstrated a statistically significant improvement in hemostasis compared to usual care (UC) (andexanet 65.7% versus UC 53%), it also showed a doubling of the rate of thromboses and thrombosis-related deaths at Day 30 in the andexanet arm, an FDA briefing document says.

A major discussion topic at the meeting, it says, will be the “increased risk of thrombosis: ANNEXA-I demonstrated an increased incidence of thrombosis (14.6% versus 6.9%) and thrombosis-related deaths at Day 30 (2.5% versus 0.9%) in the andexanet arm compared with the UC arm, respectively.These findings raise concerns regarding whether the serious risks of treatment with andexanet are acceptable in the indicated population.

Additionally, the agency says it wants the panel to also discuss the clinical meaningfulness of the benefit: “While the primary efficacy endpoint in ANNEXA-I was met, the treatment difference across arms appears to be primarily driven by one of three components of the composite endpoint, namely the volume of hematoma at 12 hours, while other clinically meaningful endpoints … were not different between the two arms,” it says. “These findings raise the question as to whether the benefit demonstrated in ANNEXA-I outweighs the serious risks.

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