MSN - AP World http://syn2.thecanadianpress.com:8080/mrss/feed/fcf7391a2f354311807f0501c16bde6a MSN - AP World Copyright © 2010-2018 The Canadian Press. All rights reserved. http://www.rssboard.org/rss-specification Sat, 21 May 2022 08:31:37 +0000 FDA panel narrowly backs COVID-19 pill from Merck http://syn2.thecanadianpress.com:8080/mrss/feed/fcf7391a2f354311807f0501c16bde6a/480fd53c443c4f729c81e7eb49438d86 A panel of U.S. health advisers narrowly backed a closely watched COVID-19 pill from Merck. The FDA panel voted 13-10 that the antiviral drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. (Dec. 1) 480fd53c443c4f729c81e7eb49438d86 Wed, 01 Dec 2021 00:28:03 +0000 SHOTLIST:RESTRICTION SUMMARY:++ONSCREEN GRAPHICS AT SOURCE++U.S. FOOD AND DRUG ADMINISTRATIONLocation unknown - 30 November 2021++EDIT STARTS ON SOUNDBITE++1. SOUNDBITE (English) Dr. Lindsey Baden, committee chair, reading voting question: "Do the known and potential benefits of molnupiravir outweigh the known and potential risk of molnupiravir when used for the treatment of mild to moderate COVID-19 in adult patients who are within five days of symptom onset and are at high risk of severe COVID-19, including hospitalization or death?"2. SOUNDBITE (English) Joyce Yu, designated federal officer: "The vote is 13 yeses, 10 nos, zero abstentions."3. SOUNDBITE (English) Dr. David Hardy, committee member:"COVID-19 is still a emergency situation. As a frontline clinician and treating patients both inpatient and outpatient, there is a need for something like this. This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderately symptomatic persons would be available."4. SOUNDBITE (English) Dr. Richard Murphy, committee member:"I voted no. It was a difficult decision, I think it came down to the fact that under the most ideal circumstances, it had a very modest efficacy and very uncertain efficacy against delta."5. SOUNDBITE (English) Jennifer Le, committee member:"There's a lot of information here, and there's a lot of safety concerns that we need to, I think, have more data for to to really have a stronger recommendation for pregnancy, let alone non-pregnant childbearing individuals."++ENDS ON SOUNDBITE++STORYLINE:U.S. health advisers have narrowly endorsed an antiviral drug from Merck to treat COVID-19. It sets the stage for an expected authorization of the first pill that Americans could take at home for the coronavirus. A Food and Drug Administration panel voted 13-10 that the drug's benefits outweigh its risks, including potential birth defects if used during pregnancy. The FDA isn't bound by the panel's Tuesday recommendation and is expected to make its own decision before the end of the year. Merck's pill could provide a much-needed therapy as cases rise in number and U.S. officials brace for the arrival of the new omicron variant.The group's recommendation came after hours of debate about the drug's modest benefits and potential safety issues. Experts backing the treatment stressed it should not be used by pregnant women and called on FDA to recommend extra precautions, including pregnancy tests for women before using the drug.The group's vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including those with conditions like obesity, asthma and old age.FDA authorization for the drug, molnupiravir, could be a major step in treating the virus. It would give doctors the first drug they could prescribe for patients to take on their own, easing the burden on hospitals and helping to curb deaths.The pill is already authorized in the U.K.__The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.===========================================================Clients are reminded: (i) to check the terms of their licence agreements for use of content outside news programming and that further advice and assistance can be obtained from the AP Archive on: Tel +44 (0) 20 7482 7482 Email: info@aparchive.com(ii) they should check with the applicable collecting society in their Territory regarding the clearance of any sound recording or performance included within the AP Television News service (iii) they have editorial responsibility for the use of all and any content included within the AP Television News service and for libel, privacy, compliance and third party rights applicable to their Territory. A panel of U.S. health advisers narrowly backed a closely watched COVID-19 pill from Merck. The FDA panel voted 13-10 that the antiviral drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. (Dec. 1) FDA panel narrowly backs COVID-19 pill from Merck