India, Sept. 30 -- Genentech, affiliated to Swiss drug major Roche Holding AG (RHHBY,RO.SW,ROG.SW) announced Wednesday that the U.S. Food and Drug Administration has accepted its New Drug Application or NDA under priority review for fenebrutinib in both relapsing and primary progressive multiple sclerosis, a chronic disease.
Fenebrutinib is an investigational non-covalent Bruton's tyrosine kinase or BTK inhibitor for the treatment of relapsing multiple sclerosis or RMS and primary progressive multiple sclerosis or PPMS.
Genentech noted that Fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both RMS and PPMS.
The filing acceptance is based on data from the comprehensive clinical program, including the Phase ...