Drugs

Pfizer Seeking EUA for ‘Promising ’ Covid Antiviral

Pfizer plans to soon submit to FDA data as part of its ongoing rolling submission seeking an Emergency Use Authorization for the Covid-19 oral antiviral candidate, Paxlovid (PF-07321332; ritonavir), after new data showed it significantly reduced hospitalization and death.

An interim analysis of 1,200 patients in the Phase 2/3 EPIC-HR study of non-hospitalized high-risk adults with Covid-19 showed an 89% reduction in risk of Covid-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset, according to Pfizer.

The company says that 0.8% of patients who received Paxlovid were hospitalized through Day 28 compared to 7.0% of patients who received placebo and were hospitalized or died. “Similar reductions in Covid-19-related hospitalization or death were observed in patients treated within five days of symptom onset,” it says.

In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo, Pfizer says.

If authorized, Pfizer says Paxlovid would be the first oral antiviral of its kind, a specifically designed SARS-CoV-2-3CL protease inhibitor. The company expects it to be prescribed more broadly as an at-home treatment to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure.

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