Shots:
- FDA has granted Priority Review to the sBLA of Enspryng for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), with a PDUFA target action date set for Jan 10, 2027. Filing is also under EMA’s review, with a decision expected in Q3’27
- sBLA was supported by the P-III (METEOROID) trial data, assessing Enspryng(60, 120 or 180mg based on body weight; SC) vs PBO, administered at 0, 2 & 4wks., then Q4W thereafter in pts (≥12yrs.) with MOGAD
- Trial met its 1EP, showing Enspryng reduced the risk of a new relapse by 68%; 87% remained relapse-free at 48wks. vs 67%, with significant improvements across 2EPs, incl. annualized relapse rate, MRI lesion activity & rescue therapy use
Ref: Businesswire | Image: Genentech | Press Release
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