US FDA approves higher dose of Regeneron’s eye disease drug Eylea By Reuters

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<span>© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo</span><br />
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<p>By Jahnavi Nidumolu</p>
<p>(Reuters) -The U.S. Food and Drug Administration approved a higher dose version of Regeneron (NASDAQ:) Pharmaceuticals’ drug Eylea for treatment of a disease that is a leading cause of blindness among the elderly, the company said in a statement on Friday. </p>
<p>The drug, Eylea HD, is priced at $2,625 per single-use vial in the U.S. and is used to treat patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy (DR), Regeneron said. </p>
<p>Eylea, which is jointly developed with Bayer (OTC:), is normally given in doses of 2 milligrams every eight weeks. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 mg at longer intervals without any additional safety issues.</p>
<p>In June, the FDA declined to approve the higher dose version of Eylea and said it had outstanding questions, citing an ongoing review of inspection at third-party manufacturer Catalent (NYSE:) . </p>
<p>Earlier in the day, the FDA approved another Regeneron drug, branded as Veopoz to treat a rare blood disease CHAPLE. </p>
<p>With Veopoz’s approval, the company said earlier that the pre-approval inspection issues related to the marketing application of Eylea HD, or aflibercept, has been addressed.</p>
<p>An estimated 1.4 million people in the U.S. have wet AMD, according to Regeneron. </p>
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<br /><a href="https://www.investing.com/news/stock-market-news/us-fda-approves-regenerons-8mg-dose-of-eye-disease-drug-eylea-3157538">Source link </a></p><p>The post <a href="https://forextraderhub.com/us-fda-approves-higher-dose-of-regenerons-eye-disease-drug-eylea-by-reuters.html">US FDA approves higher dose of Regeneron’s eye disease drug Eylea By Reuters</a> first appeared on <a href="https://forextraderhub.com">Forex Trader Hub</a>.</p>