Drugs

Merck’s Covid Drug has 52% Risk Reduction: FDA

An FDA advisory committee briefing document says data show that Merck’s oral antiviral molnupiravir (MOV) was associated with a relative risk reduction of 52% in hospitalization or death compared to placebo in adults with mild-to-moderate Covid-19 and at high risk for progression to severe disease. Committee members are scheduled 11/30 to discuss and vote on the antiviral’s potential emergency use authorization. If authorized, MOV would be a more convenient option for treating Covid patients than the current monoclonal antibodies that require intravenous or subcutaneous administration, the agency notes.

On the safety side, FDA cites “the known and potential risks of MOV, specifically the nonclinical findings of mutagenicity, embryo-fetal toxicity, and impaired bone and cartilage growth, as well as the potential for MOV to enhance SARS-CoV-2 evolution or immune escape.”

The briefing document also says MOV should not be authorized for hospitalized patients because “benefit of treatment with MOV was not observed in participants already hospitalized due to Covid-19... However, should a patient require hospitalization after starting treatment with MOV, the patient may complete the full five-day treatment course at the healthcare provider’s discretion.”

Additionally, FDA says MOV should not be authorized for use during pregnancy because there are no clinical scenarios where the benefit outweighs the risk. It also offers this alternative approach for when the antiviral’s use during pregnancy could be considered: “Under this alternative approach, MOV would not be recommended for use during pregnancy and information would be provided to prescribers regarding the potential risks of use in pregnancy through a Warning and Precaution, however, prescribers could use MOV during pregnancy at their discretion in certain clinical scenarios where the benefits were thought to outweigh the risks.”

FDA’s briefing document also offers another means of optimizing benefit-risk is through patient selection. “The known and potential risks of MOV may be more acceptable in patients with the greater prospect of benefit,” it says, adding that various subgroup analyses were conducted and the literature was reviewed to help better identify patient selection.

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