Kaitlyn D’Onofrio

DocwireNews

The U.S. Food &amp; Drug Administration (FDA) has approved dupilumab &ldquo;as an add-on maintenance treatment&rdquo; for patients aged 12 years and older with moderate-to-severe asthma &ldquo;with an eosinophilic phenotype or with oral corticosteroid dependent asthma,&rdquo; according to the <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf">FDA&rsquo;s product label</a>.&nbsp;Dupilumab, marketed as&nbsp;Dupixent, is manufactured by Sanofi and&nbsp;Regeneron Pharmaceuticals. The FDA recommends that, in the treatment of asthma, it is injected at an initial dose of 400 mg (two 200-mg injections) followed by 200 mg&nbsp;every two weeks, or at an initial dose of 600 mg (two 300-mg injections) followed by 300 mg&nbsp;every two weeks.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Great news. Dupilumab will be a great drug for asthma!
&mdash; Dr. James R. Baker (@JRB_UMFA) <a href="https://twitter.com/JRB_UMFA/status/1053542232454774785?ref_src=twsrc%5Etfw">October 20, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Comparative Efficacy of Anti IL-4, IL-5 and IL-13 Drugs for Treatment of Eosinophilic <a href="https://twitter.com/hashtag/Asthma?src=hash&amp;ref_src=twsrc%5Etfw">#Asthma</a>: All except tralokinumab showed improvements in FEV1, ACQ, and AQLQ. Only reslizumab and dupilumab were associated with significant reductions in exacerbations <a href="https://t.co/sN93RLU17V">https://t.co/sN93RLU17V</a>
&mdash; Juan C Ivancevich MD (@Aller_MD) <a href="https://twitter.com/Aller_MD/status/1053435672999223296?ref_src=twsrc%5Etfw">October 20, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The FDA&rsquo;s approval follows three randomized, placebo-controlled, multicenter trials including a total of 2,888 adult and adolescent moderate-to-severe asthma patients. Results from the largest trial, the second one, were published in the&nbsp;New England Journal of Medicine. Uncontrolled asthma patients (n = 1,902, age&nbsp;&ge;&nbsp;12 years) were randomly assigned in a 2:2:1:1 ratio&nbsp;to receive add-on subcutaneous&nbsp;dupilumab&nbsp;at a dose of 200 or 300 mg every&nbsp;two&nbsp;weeks or matched-volume placebos for 52 weeks.&nbsp;The 200 mg&nbsp;dupilumab&nbsp;group had a 47.7% lower annualized rate of severe asthma exacerbations than the&nbsp;matched-volume&nbsp;placebo group, with similar results observed in the 300 mg groups. At 12 weeks, the 200 mg&nbsp;dupilumab&nbsp;group had a 0.32-liter increase in&nbsp;forced expiratory volume in 1 second&nbsp;(difference vs. matched placebo, 0.14 liters;&nbsp;P&nbsp;&lt;&nbsp;0.001); the higher dose group&nbsp;had similar outcomes.&nbsp;For patients with a blood eosinophil count&nbsp;&ge;&nbsp;300/cubic mm, the annualized severe asthma exacerbations rate in the 200 mg&nbsp;dupilumab&nbsp;group was&nbsp;0.37 (95% CI, 0.29 to 0.48), compared with&nbsp;1.08 (95% CI, 0.85 to 1.38)&nbsp;for the&nbsp;matched-volume&nbsp;placebo group&nbsp;(65.8% lower rate with&nbsp;dupilumab&nbsp;than with placebo; 95% CI, 52.0 to 75.6). The 300 mg dose groups&nbsp;yielded similar outcomes.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
BREAKING: Dupilumab (Dupixent) approved by the <a href="https://twitter.com/hashtag/FDA?src=hash&amp;ref_src=twsrc%5Etfw">#FDA</a> for asthma indication<a href="https://t.co/OZVpw0YUNg">https://t.co/OZVpw0YUNg</a>
&mdash; HCPLive (@HCPLiveNews) <a href="https://twitter.com/HCPLiveNews/status/1053405801426153473?ref_src=twsrc%5Etfw">October 19, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><blockquote class="twitter-tweet" data-width="500" data-dnt="true">
This is SUCH GOOD NEWS for our severe <a href="https://twitter.com/hashtag/asthma?src=hash&amp;ref_src=twsrc%5Etfw">#asthma</a> and <a href="https://twitter.com/hashtag/AERD?src=hash&amp;ref_src=twsrc%5Etfw">#AERD</a> patients with <a href="https://twitter.com/hashtag/nasalpolyps?src=hash&amp;ref_src=twsrc%5Etfw">#nasalpolyps</a>. Fingers crossed that we get FDA approval for dupilumab within the week for asthma. Many of our patients are waiting for it. <a href="https://t.co/23X2Vbr2CG">https://t.co/23X2Vbr2CG</a>
&mdash; Tanya Laidlaw MD (@TanyaLaidlawMD) <a href="https://twitter.com/TanyaLaidlawMD/status/1053045177819037696?ref_src=twsrc%5Etfw">October 18, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The FDA previously approved&nbsp;dupilumab&nbsp;to treat adults with moderate-to-severe atopic dermatitis.&nbsp;According to the FDA, among asthma patients, the most&nbsp;frequent&nbsp;adverse reactions (incidence &ge;&nbsp;1%) are injection site&nbsp;reactions, oropharyngeal pain, and eosinophilia.&nbsp;<a href="https://proddocwire.wpengine.com/pulmonology/asthma-trigger-perceptions-are-associated-with-work-disability/">Asthma trigger perceptions are associated with work disability</a>&nbsp;<a href="https://proddocwire.wpengine.com/cardiology/poor-management-asthma-linked-atrial-fibrillation-risk/">Poor Management of Asthma Linked to Atrial Fibrillation Risk</a>&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/impact-asthma-control-children/">Environmental Factors Do Not Largely Impact Asthma Control in Children</a>&nbsp;<a href="https://proddocwire.wpengine.com/pulmonology/burden-of-disease-associated-with-asthma-among-the-adult-general-population-of-five-middle-eastern-countries-results-of-the-snapshot-program/">Burden of disease associated with asthma among the adult general population of five Middle Eastern countries: Results of the SNAPSHOT program</a>&nbsp;Sources:&nbsp;<a href="https://www.medscape.com/viewarticle/903761?nlid=125696_3901&amp;src=wnl_newsalrt_181022_MSCPEDIT&amp;uac=305549CV&amp;impID=1777166&amp;faf=1#vp_2">Medscape</a>,<a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1804092?query=featured_home"> NEJM</a>,&nbsp;<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf">FDA</a>

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FDA Approves Dupilumab as ‘Add-on’ for Moderate-to-severe Asthma Patients

Asthma

The U.S. Food &amp; Drug Administration (FDA) has approved dupilumab “as an add-on maintenance treatment” for patients aged 12 years and older with moderate-to-severe ...

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