US FDA Extends Review Period for BioArctic's Co-developed Alzheimer's Therapy
8 maj, 09:52
03:52 AM EDT, 05/08/2026 (MT Newswires) -- BioArctic (BIOA-B.ST) said Friday the US Food and Drug Administration extended the review period for the supplemental biologics license application for its co-developed Alzheimer's disease treatment Leqembi Iqlik, or lecanemab, by three months.
The US regulator has now set Aug. 24 as the new action date for the application submitted by Eisai, the Swedish biopharmaceutical company's partner.
The regulator did not raise any concerns regarding the approvability of Leqembi Iqlik as a starting dose but requested additional information and more time to complete its review of the submitted materials, the company noted.
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US FDA Extends Review Period for BioArctic's Co-developed Alzheimer's Therapy
8 maj, 09:52
03:52 AM EDT, 05/08/2026 (MT Newswires) -- BioArctic (BIOA-B.ST) said Friday the US Food and Drug Administration extended the review period for the supplemental biologics license application for its co-developed Alzheimer's disease treatment Leqembi Iqlik, or lecanemab, by three months.
The US regulator has now set Aug. 24 as the new action date for the application submitted by Eisai, the Swedish biopharmaceutical company's partner.
The regulator did not raise any concerns regarding the approvability of Leqembi Iqlik as a starting dose but requested additional information and more time to complete its review of the submitted materials, the company noted.
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