Alder BioPharmaceuticals has submitted a Biologics License Application to the Food and Drug Administration (FDA) for eptinezumab, an investigational monoclonal antibody (mAB) for migraine prevention. 

Eptinezumab works by targeting the calcitonin gene-related peptide (CGRP). The BLA is supported by data from two phase 3, placebo-controlled trials, PROMISE 1 and PROMISE 2, which evaluated eptinezumab for episodic and chronic migraine prevention, respectively.

Results from PROMISE 1 (N=888) showed that treatment with eptinezumab led to statistically significant reductions in monthly migraine days from baseline compared with placebo (-4.3 monthly migraine days for eptinezumab 300mg and -3.9 days for epitinezumab 100mg compared with an average -3.2 days for placebo). In PROMISE 2 (N=1072), epitinezumab-treated patients had a reduction of 8.2 monthly migraine days from baseline compared with 5.6 days for placebo.

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Unlike other CGRP inhibitors, which are administered by subcutaneous injection, eptinezumab would be administered as a quarterly intravenous infusion; the Company states that this allows for 100% of the dose to be available for selectively inhibiting CGRP. “If approved, eptinezumab will be the first quarterly infusion therapy for migraine prevention designed specifically for rapid, effective, and sustained suppression of migraine,” said Bob Azelby, chief executive officer of Alder. 

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