Replies to post #240522 on Biotech Values

[vinmantoo]

MRK’s presenter at the FDA adcomm just said that he has no valid explanation for the observed fall-off in Molnupiravir’s efficacy relative to placebo in the portion of the trial following the interim analysis other than that the placebo arm overperformed (LOL).

Maybe MRK should try to get the placebo approved as well as Molnupiravir! :)

[DewDiligence]

FDA adcomm endorses Molnupiravir EUA by_13-10_vote:

Voting results by member, for $MRK molnupiravir: https://t.co/wpaNHTdNMH pic.twitter.com/weXlQvAUJd

— Ned Pagliarulo (@NedPagliarulo) November 30, 2021

If Molnupiravir weren’t the first oral antiviral for COVID to be considered, it almost certainly would’ve been rejected by the panel, IMO.

[jfmcrr]

MRK’s presenter at the FDA adcomm just said that he has no valid explanation for the observed fall-off in Molnupiravir’s efficacy relative to placebo in the portion of the trial following the interim analysis other than that the placebo arm overperformed (LOL).

Prolly improper dosing or insufficient dilution of placebo. Subjects were subjected to excessively high levels of non treatment.

[DewDiligence]

MRK—Lagevrio misses_primary_endpoint_in_large_Oxford_U_trial:

https://ca.finance.yahoo.com/news/merck-ridgeback-biotherapeutics-clinical-non-235000071.html

The PANORAMIC study, a UK-based clinical trial sponsored by the University of Oxford, included 25,783 participants who were randomized to open label treatment with LAGEVRIO plus usual care (n=12,821) or usual care alone (n=12,962); mean age of participants was 56.6 years. Primary outcome data were available in 25,000 (97%) participants. Nearly all (>98%) participants were vaccinated, with approximately 95% receiving three or more doses of a SARS-CoV-2 vaccine.

In the preliminary analysis, the primary endpoint of reduction of hospitalizations and deaths within 28 days of randomization, compared to usual care, was not met; 0.8% of patients in both the LAGEVRIO group (n=103/12,516) and the usual care group (n=96/12,484) were hospitalized or died in the first 28 days.

Separately, in a retrospective study based on electronic medical records of high-risk patients in Israel, Lagevrio showed a benefit in reducing hospitalizations and death in the patients age 65+ but not in patients age 40-64.

Bottom line: Legevrio (molnupiravir) remains a poor choice for treating COVID. It is being prescribed only when Paxlovid is either unavailable or contra-indicated due to drug-drug interactions (from ritonavir).