- Co will apply for US approval for the pill as soon as possible
- If approved, it would be the first oral COVID-19 antiviral drug
- Merck shares recover in the pre-market
- The US government has agreed to buy 1.7 million courses at $ 700 per course
Oct. 1 (Reuters) – Merck & Co Inc’s (MRK.N) experimental oral drug for COVID-19, molnupiravir, reduced the likelihood of hospitalization or death for patients at severe disease risk by approximately, according to preliminary results of the clinical trial 50% announced on Friday.
Merck and its partner Ridgeback Biotherapeutics plan to approve the pill as soon as possible in the US for emergencies and to file applications with regulatory authorities worldwide. Due to the positive results, the phase 3 study will be terminated prematurely on the recommendation of external monitors.
“This will change the dialogue about how to deal with COVID-19,” Robert Davis, Merck’s chief executive officer, told Reuters.
If approved, molnupiravir, believed to introduce flaws in the virus’s genetic code, would be the first oral antiviral drug for COVID-19.
The news sent Merck shares up almost 8% in pre-market New York trading.
Rivals like Pfizer Inc (PFE.N) and Swiss Pharma Roche Holding AG (ROG.S) are racing to develop an easy-to-administer antiviral pill against COVID-19, but so far only antibody cocktails that have to be administered intravenously – are approved for the treatment of non-inpatient COVID-19 patients.
A scheduled interim analysis of 775 patients in the Merck study found that 7.3% of the patients who received molnupiravir were either hospitalized or died 29 days after treatment, compared with 14.1% of the placebo patients. There were no deaths in the molnupiravir group, but there were eight deaths in placebo patients.
“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are badly needed,” said Wendy Holman, CEO of Ridgeback, in a statement.
Scientists hailed the potential new treatment for the prevention of serious illnesses from the virus, which has killed nearly 5 million people worldwide.
“The availability of a well-tolerated, potent oral antiviral agent will be particularly useful to complement vaccination to reduce the proportion of patients in need of hospital treatment,” said Professor Penny Ward, visiting professor of pharmaceutical medicine at King’s College London .
In the study, which included patients from around the world, molnupiravir was taken every 12 hours for five days.
The study enrolled patients with laboratory-confirmed mild to moderate COVID-19 who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease progression, such as obesity or old age.
Merck said virus sequencing done to date shows molnupiravir to be effective against all variants of the coronavirus, including the highly transmissible delta.
The company said the incidence of side effects between molnupiravir and placebo patients was similar, but did not provide details of the side effects.
Data from Merck shows that molnupiravir is unable to induce genetic changes in human cells, but men participating in its studies must refrain from heterosexual intercourse or consent to the use of contraceptives. Women of childbearing potential cannot be pregnant and must also use contraception.
Merck expects to produce 10 million treatment cycles by the end of 2021, with more doses coming next year.
The company has a contract with the US government to supply 1.7 million courses of molnupiravir at a cost of $ 700 per course.
CEO Davis said Merck has made similar agreements with other governments around the world and is in discussion with others. The company plans to implement a tiered pricing approach based on the country’s income criteria.
Merck has also agreed to license the drug to several India-based generic drug companies that could deliver the treatment to low- and middle-income countries.
Molnupiravir is also being studied in a phase 3 study to prevent coronavirus infection in people exposed to the virus.
Merck officials said it was unclear how long the FDA review of the drug would take.
“I believe they will try to work on it diligently,” said Dean Li, director of Merck’s research laboratories.
Reporting from Deena Beasley; Additional reporting from Josephine Mason, Lincoln Feast Editor, Kirsten Donovan
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