Biogen Gets FDA Approval for Leqembi Iqlik as Initiation Dose for Early Alzheimer's Disease
Biogen (BIIB) and Eisai said late Monday that the US Food and Drug Administration has approved a supplemental biologics license application for Leqembi Iqlik, a once-weekly subcutaneous injection, as an initiation dose for the treatment of early Alzheimer's disease. Leqembi Iqlik is administered via an auto-injector, and the approved initiation regimen is 500 mg given once weekly as two 250 mg injections, each delivered in about 15 seconds. It may also be used for maintenance dosing at 360 mg once weekly after 18 months of intravenous or subcutaneous treatment. The companies expect Leqembi Iqlik for initiation dosing to be available through US specialty pharmacies in late August.
Biogen (BIIB) and Eisai said late Monday that the US Food and Drug Administration has approved a supplemental biologics license application for Leqembi Iqlik, a once-weekly subcutaneous injection, as an initiation dose for the treatment of early Alzheimer's disease.
Leqembi Iqlik is administered via an auto-injector, and the approved initiation regimen is 500 mg given once weekly as two 250 mg injections, each delivered in about 15 seconds.
It may also be used for maintenance dosing at 360 mg once weekly after 18 months of intravenous or subcutaneous treatment.
The companies expect Leqembi Iqlik for initiation dosing to be available through US specialty pharmacies in late August.