Benzinga | Jan 25, 2022 12:19PM EST

Genentech's Evrysdi Application Under FDA Priority Review For Use In Babies Below 2 Months

The FDA has granted priority review for Genentech's, a unit of Roche Holdings AG (OTC:RHHBY) supplemental marketing application for Evrysdi (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA).

* Evrysdi is already approved to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older.

* The submission incorporates interim data from the RAINBOWFISH study.

* The data showed that most pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting, standing, walking, and maintaining the ability to swallow following 12 months of treatment.

* No treatment-related serious adverse events were reported in any babies treated with Evrysdi through the interim safety analysis period (n=12).

* The latest results from the RAINBOWFISH study will be presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference in March 2022.

* Price Action: RHHBY shares are down 1.59% at $47.04 during the market session on the last check Tuesday.