Kaitlyn D’Onofrio

DocwireNews

The U.S. Food &amp; Drug Administration (FDA) has approved&nbsp;baloxavir&nbsp;marboxil&nbsp;to treat acute uncomplicated influenza in patients aged 12 years and older who have had symptoms for&nbsp;no more than&nbsp;48 hours. It is the first antiviral flu therapy approved by the FDA in nearly 20 years.&nbsp;Baloxavir&nbsp;marboxil, marketed as&nbsp;Xofluza,&nbsp;received priority review from the FDA. It&nbsp;was tested in two randomized controlled clinical trials that included 1,832 total patients who received&nbsp;baloxavir&nbsp;marboxil, a placebo, or another antiviral flu treatment within 48 hours of initial symptoms. In both trials,&nbsp;baloxavir&nbsp;marboxil&nbsp;alleviated symptoms faster than placebo.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
First new antiviral <a href="https://twitter.com/hashtag/flu?src=hash&amp;ref_src=twsrc%5Etfw">#flu</a> treatment with a novel mechanism of action approved by <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> in nearly 20 years: Xofluza (baloxavir marboxil). Time to alleviation of symptoms was similar to Tamiflu in phase 3 trial, with lower viral load: <a href="https://t.co/axFdf1GwQC">https://t.co/axFdf1GwQC</a>
&mdash; jenabbasi (@jenabbasi) <a href="https://twitter.com/jenabbasi/status/1055137149127921664?ref_src=twsrc%5Etfw">October 24, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Results from the second trial were published in the&nbsp;New England Journal of Medicine&nbsp;in September. In this trial, patients received&nbsp;weight-based doses of&nbsp;baloxavir&nbsp;marboxil&nbsp;(40 or 80 mg), 75 mg doses of&nbsp;oseltamivir&nbsp;twice a day for five days, or placebo. Median time to symptom relief in the&nbsp;baloxavir&nbsp;marboxil&nbsp;groups was 23.4 to 28.2 hours shorter than in the placebo group (P&nbsp;&lt; 0.05). Among patients with influenza A (H3N2) infection, median symptom alleviation time&nbsp;was 53.7 hours (95% confidence interval [CI], 49.5 to 58.5) with&nbsp;baloxavir&nbsp;marboxil, compared with 80.2 hours (95% CI, 72.6 to 87.1) with placebo (P&nbsp;&lt;&nbsp;0.001).&nbsp;Viral load reduction one day after treatment was greater in&nbsp;baloxavir&nbsp;marboxil&nbsp;patients than those receiving placebo or oseltamivir. There was no significant difference in median time to alleviation of symptoms between the&nbsp;baloxavir&nbsp;marboxil&nbsp;and oseltamivir groups.&nbsp;Adverse events&nbsp;occurred&nbsp;in 20.7% of&nbsp;baloxavir&nbsp;marboxil&nbsp;patients, 24.6% of placebo&nbsp;patients, and 24.8% of oseltamivir&nbsp;patients.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
<a href="https://twitter.com/hashtag/baloxavir?src=hash&amp;ref_src=twsrc%5Etfw">#baloxavir</a> is approved in the US (<a href="https://twitter.com/hashtag/Xofluza?src=hash&amp;ref_src=twsrc%5Etfw">#Xofluza</a>), first <a href="https://twitter.com/hashtag/influenza?src=hash&amp;ref_src=twsrc%5Etfw">#influenza</a> antiviral in Nearly 20 Years <a href="https://t.co/6do0HKs0Ql">https://t.co/6do0HKs0Ql</a> via <a href="https://twitter.com/Medscape?ref_src=twsrc%5Etfw">@medscape</a>
&mdash; Francisco Marty, MD (@FranciscoMarty_) <a href="https://twitter.com/FranciscoMarty_/status/1055175932791742464?ref_src=twsrc%5Etfw">October 24, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Diarrhea and bronchitis were the most common adverse effects associated with&nbsp;baloxavir&nbsp;marboxil, according to the FDA.&nbsp;&ldquo;With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,&rdquo; said FDA Commissioner Scott Gottlieb, M.D.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Major <a href="https://twitter.com/hashtag/flu?src=hash&amp;ref_src=twsrc%5Etfw">#flu</a> <a href="https://twitter.com/hashtag/influenza?src=hash&amp;ref_src=twsrc%5Etfw">#influenza</a> development: approval of baloxavir <a href="https://t.co/Nw3MILtIN8">https://t.co/Nw3MILtIN8</a>
&mdash; Amesh Adalja (@AmeshAA) <a href="https://twitter.com/AmeshAA/status/1055158181767323660?ref_src=twsrc%5Etfw">October 24, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The commissioner also stressed the importance of getting a flu shot.&nbsp;&ldquo;While there are several FDA-approved antiviral drugs to treat flu, they&rsquo;re not a substitute for yearly vaccination,&rdquo; he said.&nbsp;&ldquo;Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.&rdquo;&nbsp;<a href="https://twitter.com/Achenbach_ID/status/1055143452567109635">https://twitter.com/Achenbach_ID/status/1055143452567109635</a>For More Coverage Click <a href="https://proddocwire.wpengine.com/docwire-pick/future-of-medicine-picks/fda-approves-first-new-flu-treatment-in-20-years/">Here</a><a href="https://proddocwire.wpengine.com/docwire-pick/baloxavir-marboxil-flu-drug/">Single-dose Flu Drug May Shorten Symptoms</a>&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/rheumatology-picks/could-a-flu-vaccine-reduce-mortality-in-rheumatoid-arthritis-patients/">Could a Flu Vaccine Reduce Mortality in Rheumatoid Arthritis Patients?</a>&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/psoriasis-patients-less-likely/">Psoriasis Patients Less Likely to Receive Flu Shot than RA Patients</a>&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/recommend-flu-shot-everyone/">AAP, CDC Recommend Flu Shot for Everyone Aged Six Months and Older</a>&nbsp;Sources:&nbsp;<a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1716197">NEJM</a>,&nbsp;<a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624226.htm">FDA</a>, <a href="https://www.medscape.com/viewarticle/903911">Medscape</a>

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FDA Approves First Flu Antiviral in Almost Two Decades

Infectious Disease

The U.S. Food &amp; Drug Administration (FDA) has approved baloxavir marboxil to treat acute uncomplicated influenza in patients aged 12 years and older who have had ...

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