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		<title>Pfizer seeking FDA emergency use authorization for COVID-19 antiviral pill</title>
		<link>https://cincylink.com/2021/11/17/pfizer-seeking-fda-emergency-use-authorization-for-covid-19-antiviral-pill/</link>
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		<pubDate>Wed, 17 Nov 2021 05:07:20 +0000</pubDate>
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					<description><![CDATA[There's another potential game-changer in the fight against this pandemic.Pfizer has now applied for Food and Drug Administration emergency authorization for its COVID-19 antiviral pill.The pill is made for people who have already been diagnosed with COVID-19, are unvaccinated and at a high risk for becoming severely ill.The pill would be sold under the brand &#8230;]]></description>
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<p>
					There's another potential game-changer in the fight against this pandemic.Pfizer has now applied for Food and Drug Administration emergency authorization for its COVID-19 antiviral pill.The pill is made for people who have already been diagnosed with COVID-19, are unvaccinated and at a high risk for becoming severely ill.The pill would be sold under the brand name Paxlovid, and if granted, could be available in just weeks.In a clinical trial with adults 18 and up, Pfizer found its antiviral pill cuts hospitalization and death risks by nearly 90 percent when taken within three days of onset symptoms.Most COVID-19 treatments right now require an IV or injection.Great Britain authorized Merck's COVID-19 pill earlier this month, and it's pending approval here in the United States.The US government is expected to cover the cost for both medications, estimated to be around $700 per treatment.Side effects of this pill were mild to moderate according to Pfizer.Both Pfizer's pill and Merck's pill attack the coronavirus by interfering with the ability to replicate itself.
				</p>
<div>
					<strong class="dateline">CINCINNATI —</strong> 											</p>
<p>There's another potential game-changer in the fight against this pandemic.</p>
<p>Pfizer has now applied for Food and Drug Administration emergency authorization for its COVID-19 antiviral pill.</p>
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<p>The pill is made for people who have already been diagnosed with COVID-19, are unvaccinated and at a high risk for becoming severely ill.</p>
<p>The pill would be sold under the brand name Paxlovid, and if granted, could be available in just weeks.</p>
<p>In a clinical trial with adults 18 and up, Pfizer found its antiviral pill cuts hospitalization and death risks by nearly 90 percent when taken within three days of onset symptoms.</p>
<p>Most COVID-19 treatments right now require an IV or injection.</p>
<p>Great Britain authorized Merck's COVID-19 pill earlier this month, and it's pending approval here in the United States.</p>
<p>The US government is expected to cover the cost for both medications, estimated to be around $700 per treatment.</p>
<p>Side effects of this pill were mild to moderate according to Pfizer.</p>
<p>Both Pfizer's pill and Merck's pill attack the coronavirus by interfering with the ability to replicate itself.</p>
</p></div>
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<br /><a href="https://www.wlwt.com/article/pfizer-fda-emergency-use-authorization-covid-19-antiviral-pill/38272588">Source link </a></p>
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		<title>Merck seeks FDA emergency use authorization for antiviral COVID-19 treatment</title>
		<link>https://cincylink.com/2021/10/12/merck-seeks-fda-emergency-use-authorization-for-antiviral-covid-19-treatment/</link>
					<comments>https://cincylink.com/2021/10/12/merck-seeks-fda-emergency-use-authorization-for-antiviral-covid-19-treatment/#respond</comments>
		
		<dc:creator><![CDATA[cincylink]]></dc:creator>
		<pubDate>Tue, 12 Oct 2021 04:28:05 +0000</pubDate>
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					<description><![CDATA[Merck said Monday it is seeking U.S. Food and Drug Administration emergency use authorization for its experimental antiviral COVID-19 treatment, molnupiravir.If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to fight COVID-19. It comes in capsule form.Merck said it is asking for authorization for the &#8230;]]></description>
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<p>
					Merck said Monday it is seeking U.S. Food and Drug Administration emergency use authorization for its experimental antiviral COVID-19 treatment, molnupiravir.If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to fight COVID-19. It comes in capsule form.Merck said it is asking for authorization for the capsules to treat infected adults who are at risk of progressing to severe COVID-19 disease or hospitalization. Its submission is based on a study that was stopped at the interim point because the drug was working so well in more than 700 patients randomly assigned to take either molnupiravir or a placebo."At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients," the company said in a statement."Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo." None of the volunteers in the trial had been vaccinated."The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," Merck CEO and President Robert Davis said in the statement.Data from the trial has not yet been peer-reviewed or published."Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022," the company said.It has already sold 1.7 million treatment courses to the U.S. government. The company said it will offer tiered pricing to provide access around the world, and will work with generic drug manufacturers to speed availability to low- and middle-income countries.At a White House COVID-19 briefing last week, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the trial results "very encouraging," but said the drug needs close scrutiny by the FDA."It is very important that this now must go through the usual process of careful examination of the data by the Food and Drug Administration both for effectiveness, but also for safety, because whenever you introduce a new compound, safety is very important," Fauci said, noting that vaccines remain "our best tools against COVID-19" by preventing infection and illness, rather than treating it.
				</p>
<div>
<p>Merck said Monday it is seeking U.S. Food and Drug Administration emergency use authorization for its experimental antiviral COVID-19 treatment, molnupiravir.</p>
<p>If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to fight COVID-19. It comes in capsule form.</p>
<p>Merck said it is asking for authorization for the capsules to treat infected adults who are at risk of progressing to severe COVID-19 disease or hospitalization. Its submission is based on a study that was stopped at the interim point because the drug was working so well in more than 700 patients randomly assigned to take either molnupiravir or a placebo.</p>
<p>"At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients," the company said in a statement.</p>
<p>"Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo." None of the volunteers in the trial had been vaccinated.</p>
<p>"The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," Merck CEO and President Robert Davis said in the statement.</p>
<p>Data from the trial has not yet been peer-reviewed or published.</p>
<p>"Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022," the company said.</p>
<p>It has already sold 1.7 million treatment courses to the U.S. government. The company said it will offer tiered pricing to provide access around the world, and will work with generic drug manufacturers to speed availability to low- and middle-income countries.</p>
<p>At a White House COVID-19 briefing last week, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the trial results "very encouraging," but said the drug needs close scrutiny by the FDA.</p>
<p>"It is very important that this now must go through the usual process of careful examination of the data by the Food and Drug Administration both for effectiveness, but also for safety, because whenever you introduce a new compound, safety is very important," Fauci said, noting that vaccines remain "our best tools against COVID-19" by preventing infection and illness, rather than treating it.</p>
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