acf/google-ad-placement

<ul>
	<li>The&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/03/31211962/fda-accepted-eisai-biogens-supplemental-biologics-license-application-for-leqembi-lecanemab-irmb-" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA has accepted</a>&nbsp;Eisai Co Ltd&nbsp;ESALY and&nbsp;Biogen Inc&#39;s&nbsp;BIIB supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection, supporting the conversion of the accelerated approval of Leqembi to a traditional approval.&nbsp;</li>
	<li>The Leqembi application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.&nbsp;</li>
	<li>The FDA plans to hold an Advisory Committee to discuss this application but has not publicly announced the meeting date.</li>
	<li>Also Read:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/12/30177281/biogens-alzheimers-antibody-might-have-a-third-death-associated-with" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Biogen&#39;s Alzheimer&#39;s Antibody Might Have A Third Death Associated With</a>.</li>
	<li>Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils) and insoluble forms of amyloid beta (A&beta;).</li>
	<li>The&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/01/30316003/fda-approves-biogens-second-alzheimers-treatment-under-accelerated-pathway" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA approved the treatment</a>&nbsp;under the Accelerated Approval Pathway for Alzheimer&#39;s Disease (AD).&nbsp;</li>
	<li>Treatment with Leqembi should only be initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of A&beta; pathology.&nbsp;</li>
	<li>Eisai leads Leqembi development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.</li>
	<li>Price Action:&nbsp;BIIB shares are down 0.43% at $269.11 on the last check Monday.</li>
</ul>

Biotech

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