{"id":41538,"date":"2021-10-31T07:12:06","date_gmt":"2021-10-31T07:12:06","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=41538"},"modified":"2021-11-26T22:56:17","modified_gmt":"2021-11-26T22:56:17","slug":"early-efficacy-results-with-oral-molnupiravir-focus-attention-on-price-and-access","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/41538","title":{"rendered":"Early efficacy results with oral molnupiravir focuses attention on price and access"},"content":{"rendered":"
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Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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<\/span>On 1 October 2021, early results reported that a five-day course of treatment with the oral antiviral drug molnupiravir significantly halved the risk of hospitalisation or dying from COVID-19 from 14% to 7% (p=0.0012). [1]<\/strong><\/p>\n<\/div>\n

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These were planned interim results in approximately 750 non-hospitalised participants with mild to moderate COVID-19 enrolled in an ongoing phase 3 study.<\/p>\n<\/div>\n

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The results were sufficient for the study data safety monitoring board (DSMB) to recommend stopping further recruitment – with approximately 1500 participants now in the study.<\/p>\n<\/div>\n

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Molnupiravir is being developed by Merck\/MSD who announced plans to file an emergency application with the US FDA.<\/span><\/p>\n<\/div>\n

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As potentially the first oral medication in earlier infection, there was an almost immediate focus on access, after a 5-day course was priced at $700 for a pre-approval order for the US market, despite costing less than $20 to manufacture. [2]<\/span><\/p>\n<\/div>\n

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Several plans were also quickly announced, including by the Gates Foundation and the Medicines Patent Pool for access in low- and middle-income countries. [3, 4, 5]<\/span><\/p>\n<\/div>\n

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The EMA has already started a rolling review for a regulatory decision in Europe. [6]<\/span><\/p>\n

STOP PRESS<\/h3>\n

Shortly after this issue of HTB was distributed, the UK became the first country to conditionally approve molnupiravir. [7, 8]<\/strong><\/p>\n

A few weeks later, a full analysis including all participants reported lower effectiveness with 3% absolute and 30% relative reductions.<\/strong><\/p>\n

The risk of hospitalisation or death in the full analysis is 9.7% in the placebo group (68\/699) compred 6.8% (48\/709) in the molnupiravir group, This is an absolute risk reduction of 3.0% (95%CI: 0.1 to 5.9; nominal p=0.0218) and a relative risk reduction of 30% (RR 0.70; 95% CI: 0.49 to 0.99). [9]<\/strong><\/p>\n<\/div>\n

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References<\/span><\/p>\n<\/div>\n

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    \n
  1. Merck press statement. <\/b>Merck and Ridgeback\u2019s investigational oral antiviral molnupiravir reduced the risk of hospitalization or death by approximately 50 percent compared to placebo for patients with mild or moderate COVID-19 in positive interim analysis of phase 3 study. (1 October 2021).
    \n<\/span>https:\/\/www.merck.com\/news\/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat<\/a><\/li>\n
  2. CommonDreams.org. ‘Entirely unsurprising’: Merck slammed for 4,000% markup of taxpayer-funded COVID-19 drug. (6 October 2021).
    \n    https:\/\/www.commondreams.org\/news\/2021\/10\/06\/entirely-unsurprising-merck-slammed-4000-markup-taxpayer-funded-covid-drug<\/a><\/li>\n
  3. Gates provides US$120 million to support generic production of molnupiravir
    \n    https:\/\/www.statnews.com\/pharmalot\/2021\/10\/20\/covid19-merck-gates-pill-patents-who<\/a><\/li>\n
  4. Merck press statement. The Medicines Patent Pool (MPP) and Merck Enter Into License Agreement for Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, to Increase Broad Access in Low- and Middle-Income Countries. (27 October 2021).
    \n    https:\/\/www.merck.com\/news\/the-medicines-patent-pool-mpp-and-merck-enter-into-license-agreement-for-molnupiravir-an-investigational-oral-antiviral-covid-19-medicine-to-increase-broad-access-in-low-and-middle-income-countri<\/a><\/li>\n
  5. WHO-Unitaid statement on the MPP licensing agreement for molnupiravir. (27 October 2021),
    \n    https:\/\/www.who.int\/news\/item\/27-10-2021-who-unitaid-statement-on-the-mpp-licensing-agreement-for-molnupiravir<\/a><\/li>\n
  6. EMA. COVID-19: EMA starts rolling review of molnupiravir. (25 October 2021).
    \n    https:\/\/www.ema.europa.eu\/en\/news\/covid-19-ema-starts-rolling-review-molnupiravir<\/a><\/li>\n
  7. MHRA press release. First oral antiviral for COVID-19, Lagevrio (molnupiravir), approved by MHRA. *4 November 2021).
    \n    https:\/\/www.gov.uk\/government\/news\/first-oral-antiviral-for-covid-19-lagevrio-molnupiravir-approved-by-mhra<\/a><\/li>\n
  8. MHRA. Regulatory approval of Lagevrio (molnupiravir). (4 November 2021).
    \n    https:\/\/www.gov.uk\/government\/publications\/regulatory-approval-of-lagevrio-molnupiravir<\/a><\/li>\n
  9. Merck press release. Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19. (26 November 2021).
    \n    https:\/\/www.businesswire.com\/news\/home\/20211126005279\/en\/Merck-and-Ridgeback-Biotherapeutics-Provide-Update-on-Results-from-MOVe-OUT-Study-of-Molnupiravir-an-Investigational-Oral-Antiviral-Medicine-in-At-Risk-Adults-With-Mild-to-Moderate-COVID-19<\/a><\/li>\n<\/ol>\n

    This report was updated on 4 and 26 November to include updated information in the end comments.<\/em><\/p>\n<\/div>\n

    \n

    \u00a0<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 1 October 2021, early results reported that a five-day course of treatment with the oral antiviral drug molnupiravir significantly halved the risk of hospitalisation or dying from COVID-19 from 14% to 7% (p=0.0012). [1] These …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[286,283,278],"tags":[],"class_list":["post-41538","post","type-post","status-publish","format-standard","hentry","category-covid-19-treatment-access","category-covid-19-investigational-drugs","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41538","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=41538"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41538\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=41538"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=41538"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=41538"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}