Drugs

EUA for Pfizer Paxlovid Covid Pill

FDA issued a 12/22/21 emergency use authorization for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for treating mild-to-moderate Covid-19 in adults and children age 12 and older with positive results of direct SARS-CoV-2 testing who are at high risk for progressing to severe Covid-19. An agency statement says treatment with the prescription drug should be started as soon as possible after a Covid-19 diagnosis and within five days of symptom onset.

Paxlovid is not authorized for the pre-exposure or post-exposure prevention of Covid-19 or for starting treatment in those requiring hospitalization due to severe or critical Covid-19, FDA says.

The statement says nirmatrelvir inhibits a SARS-CoV-2 protein to stop the virus from replicating and ritonavir slows nirmatrelvir’s breakdown to help it remain in the body longer at higher concentrations.

In a clinical trial, the agency says, Paxlovid significantly reduced the proportion of people with Covid-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive therapeutic monoclonal antibody treatment.

Possible side effects include impaired sense of taste, diarrhea, high blood pressure, and muscle aches.

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