Oct 9, 2022
Oct 6, 2022
Merck and Ridgeback announced two real-world evidence data of Lagevrio (molnupiravir), an investigational COVID-19 drug. The first study, PANORAMIC, was conducted in the UK in highly vaccinated adults, most people of age less than 65 years. The second study, Clalit, was conducted in Israel, with most adults older than 65 with chronic heart conditions.
In the PANORAMIC study, two arms were considered; Lagevrio plus standard of care compared with standard of care alone. The primary endpoint was a reduction in hospitalization or death; 0.8% of hospitalization or death was reported in both arms.
In the Clalit study, Lagevrio was associated with fewer hospitalizations and death in older adults; however, there was no difference in the younger adults (less than 65 years of age).
Jan 18, 2022
Merck and Ridgeback Biotherapeutics announced that they had signed a long-term agreement to supply 3 million doses of molnupiravir to the United Nations Children’s Fund (UNICEF). These 3 million doses will be supplied to middle and lower-income countries.
Molnupiravir is approved in the US, Japan, and the UK for treating mild to moderate COVID19 infection.
Jan 11, 2022
GSK and Vir Biotechnology announced that they have agreed to supply an additional 600,000 doses of sotrovimab to the US government to access the drug across the nation further. GSK and Vir Biotechnology have agreed to provide 1.7 million doses of sotrovimab globally.
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GSK announced that testing the drug in live viruses and pseudoviruses showed effectiveness against the Delta and Omicron variants.
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Sotrovimab has received emergency use authorization from the US FDA in May 2021. Under the EUA, it can be used for mild-to-moderate COVID19 patients who are at risk of progressing to severe disease.
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GSK and Vir announced that they would manufacture 2 million doses of sotrovimab in the first half of 2022.
Jan 10, 2022
Novartis and Molecular Partners have announced the Part A EMPATHY clinical trial results, in which ensovibep, a DARPin antiviral therapeutic candidate, was evaluated for treating COVID19. The company announced that ensovibep is active against all variants, including Omicron.
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The companies announced that the drug met the primary endpoint of reducing the viral clearance compared to placebo. The secondary endpoints are reduction in hospitalization visits or deaths and time to recovery. Novartis will in-license ensovibep from Molecular Partners and seek accelerated access worldwide, the first being the Emergency Use Authorisation from the FDA. Novartis confirmed that it would pay CHF 150 million to Molecular Partners to in-license the product.
EMPATHY trial was conducted across the US, India, South Africa, Netherlands, and Hungary to evaluate the efficacy and safety of three doses: 75mg, 225mg, and 600mg in 407 patients. The trial included patients with mild to moderate disease in the ambulatory setting.
There was a statistically significant reduction in the viral load after eight days in the patients treated with ensovibep compared to placebo. There was a reduction in hospitalization, emergency visits, or death by 78% compared to placebo. No deaths were reported in the patients treated with ensovibep. The lowest dose of 75 mg is planned for further development.
Novartis will be responsible for the development, manufacturing, distribution, and commercialization of ensovibep.
Merck and Ridgeback's molnupiravir received Emergency Use Authorization from the US Food and Drug Administration for treating COVID19 patients who are at high risk of developing severe disease, including hospitalization and death.
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The recommended dose is 800 mg (four 200 mg capsules) every 12 hours for five days. It is recommended to complete the course to prevent the replication of the virus.
The approval is based on Phase 3 MOVe-OUT trial, which enrolled 1,433 patients. The absolute risk of hospitalization or death was reduced by 3.0% in molnupiravir versus placebo (9.7% in the placebo group vs. 6.8% in the molnupiravir arm). Nine deaths were reported in the placebo arm versus one in the molnupiravir arm.
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Molnupiravir is also in the clinical trials (MOVe-AHEAD) to determine its efficacy in spreading the infection within households.
Merck has also agreed to supply 1.75 million courses of molnupiravir to the UK. Earlier, it has agreed to provide 480,000 courses to the government of the UK, which makes it to a total of 2.23 million courses of molnupiravir. It is marketed as Lagevrio in the UK. In September 2021, molnupiravir received conditional marketing authorization in the UK.
Merck agreed to supply molnupiravir with 30 countries worldwide, including 21 European countries.
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