Biologics

EUA Approved for AstraZeneca’s Evusheld

FDA has issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prevention of Covid-19 in certain adults and pediatric patients. An agency notice says the monoclonal antibody product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual with SARS-CoV-2. The authorization also requires that individuals either have:

moderately to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and thus may not mount an adequate response to Covid-19 vaccination; or
a history of severe adverse reactions to a Covid-19 vaccine and/or component(s) of those vaccines and thus vaccination with an available Covid-19 vaccine is not recommended.

The notice says that one dose of Evusheld may be effective for pre-exposure prevention for six months. It is not authorized for individuals for the treatment of Covid-19 or post-exposure prevention of Covid-19.

According to FDA, tixagevimab and cilgavimab are long-acting monoclonal antibodies that are specifically directed against the SARS-CoV-2 spike protein and designed to block the virus’ attachment and entry into human cells. The two proteins bind to different, non-overlapping sites on the virus spike protein.

Possible side effects include hypersensitivity reactions, bleeding at the injection site, headache, fatigue, and cough.

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