Merck’s COVID-19 pill is significantly less effective in new analysis

An experimental Covid-19 treatment pill, called Molnupiravir and developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, was seen in the undated handout photo released by Merck & Co Inc. and received by Reuters on October 26, 2021. Merck & Co Inc. / Handout by REUTERS

November 26 (Reuters) – Merck & Co (MRK.N) on Friday updated data from its study of its experimental COVID-19 pill showed that the drug is significantly less effective in cutting hospitals and deaths than previously reported.

The drug-maker said his pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, his data showed an efficacy of approximately 50%, based on data from 775 patients. The drug, Molnupiravir, was developed with partner Ridgeback Biotherapeutics.

The lower efficacy of Merck’s drug may have major implications in terms of whether countries continue to purchase the pill. Interim data from 1,200 participants in Pfizer Inc. (PFE.N) trial for its experimental pill, Paxlovid, showed an 89% reduction in hospitalizations and deaths.

Merck’s shares fell 3.5% to $ 79.39 in morning trading.

Merck released the data Friday before the US.

The staff of the agency did not make their own recommendation whether the pill should be authorized.

FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for whom the drug should be authorized should be limited.

They also asked the committee to select the concerns about whether the drug could encourage the virus to mutate, and how the concerns could be mitigated.

Pills like Molnupiravir and Paxlovid may be promising new weapons in the fight against the pandemic, because they can be taken as early in home treatments to prevent COVID-19 hospitalizations and deaths. They may also become important tools in countries and areas with limited access to vaccines or low inoculation rates.

Easier treatment

The Merck and Pfizer pills are cheaper to manufacture and easier to administer than existing treatment options such as antibody therapies from Regeneron (REGN.O) and Eli Lilly (LLY.N), which are mostly administered as intravenous infusions.

The two experimental drugs have different mechanisms of action. Merck’s is designed to introduce errors in the genetic code of the virus. Pfizer’s drug, part of a class known as protease inhibitors, is designed to block an enzyme that the coronavirus needs to multiply.

Merck asked for a US. Read more

The molnupiravir arm of the study had a hospitalization and death rate of 6.8%, according to the updated data. The placebo group had a hospitalization and death rate of 9.7%.

One patient in the Molnupiravir arm died, versus nine in the placebo group.

The United Kingdom conditionally approved Molnupiravir, branded as Lagevrio, earlier this month.

Merck expects to produce 10 million courses of the treatment by the end of the year, with at least 20 million to be produced by 2022. It has a contract with the US. Per course. Several other countries have already secured millions of courses from the pill.

Merck said that data show that molenpiravir is not capable of inducing genetic changes in human cells, but people who are enrolled in his trials have to refrain from heterosexual intercourse or agree to use contraception. Women of child-bearing age also have to use birth control.

Still, the FDA said in its briefing document that there are safety concerns about potential birth defects of the drug and asked the panel to discuss whether the drug should be available to pregnant women.

Report by Manas Mishra in Bengaluru and Michael Erman in New Jersey Edited by Shounak Dasgupta, Frances Kerry and Emelia Sithole-Matarise

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