Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Wednesday that the US Food and Drug Administration (FDA) has accepted its New Drug Application for fenebrutinib under priority review for relapsing and primary progressive multiple sclerosis.

In the Phase III FENhance 1 and 2 trials, fenebrutinib reduced annualised relapse rates by 51.1% and 58.5%, respectively, versus teriflunomide over 96 weeks, while disability progression measures showed consistent positive trends favouring fenebrutinib.

In the Phase III FENtrepid study, fenebrutinib met its primary endpoint of non-inferiority to Ocrevus in reducing disability progression and numerically reduced the risk of progression by 12%.

Genentech said fenebrutinib is designed to target acute inflammation associated with relapses and chronic inflammation thought to drive disability progression by crossing the blood-brain barrier into the central nervous system.

Serious adverse event rates were 9% for both fenebrutinib and teriflunomide in FENhance 1, 11% versus 6% in FENhance 2, and 19% for both fenebrutinib and Ocrevus in FENtrepid.

The company said fenebrutinib has demonstrated a manageable safety profile across Phase III and earlier studies, with a safety database comprising more than 2,700 participants.