Showing posts with label Merck. Show all posts
Showing posts with label Merck. Show all posts

Friday, November 26, 2021

Looks like there won't be a magic pill for that, at least from Merck

 

Efficacy of Merck's molnupiravir in preventing hospitalization & death from C19 drops to 30% from 48% in October preliminary results after interim results in over 1400 patients reported, mostly because the interim placebo group hospitalization rate narrowed by 31%:
 

Merck & Co said on Friday updated data from its study on its experimental COVID-19 pill showed the drug was less effective in cutting hospitalizations and deaths than previously reported.

The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from over 1,400 patients. In October, its data showed a roughly 50% efficacy, based on data from 775 patients. ...

The company filed for a U.S. authorization of the drug molnupiravir on Oct. 11, following the interim data.

Merck said on Friday the data on molnupiravir, developed with Ridgeback Biotherapeutics, had been submitted to the U.S. Food and Drug Administration ahead of a meeting of its expert advisers on Tuesday.

The FDA's scientists are expected to publish their briefing documents ahead of the meeting as early as Friday.

The panel is expected to vote whether to recommend that the agency authorize the oral capsules for the treatment of mild-to-moderate COVID-19 in adults who are at risk of severe disease.

A planned interim analysis of the data last month showed that 7.3% of those given molnupiravir twice a day for five days were hospitalized and none had died by 29 days after the treatment. That compared with a hospitalization rate of 14.1% for patients on placebo.

In the updated data, 6.8% of those given molnupiravir were hospitalized and one person died, while the other placebo group had a hospitalization rate of 9.7%.

Reuters.


Thursday, November 11, 2021

The FDA is letting thousands die of C19 as it moves with the speed of a glacier to grant emergency use authorization to new antiviral pills proven to work

 FDA doesn't give a shit about saving lives in an emergency.

So what should we think of the FDA keeping the drug, called Paxlovid, out of the hands of the infected? The FDA’s advisory committee won’t meet to approve the Merck drug until after Thanksgiving, according to the FDA’s website . The meeting is an entirely virtual one, so this isn’t a matter of getting all the advisory committee members into one place. It’s just a matter of scheduling. The earliest we could get Paxlovid into doctors’ offices or pharmacies is mid-December. 

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