BRIEF — After Japan filing of RA drug, Astellas sets sights on other Asian countries

Astellas has submitted an application for marketing approval of peficitinib hydrobromide in Japan for the treatment of rheumatoid arthritis (RA), including prevention of structural joint damage, in patients who have an inadequate response to conventional therapy.

Peficitinib, an orally available janus kinase inhibitor discovered by the Japanese drugamaker, suppresses activation and proliferation of inflammatory cells involved in synovial inflammation and joint destruction in RA patients through inhibition of various inflammatory cytokine signaling pathways.

The submission is based mainly on the results obtained from two Phase III trials of peficitinib in RA patients who had an inadequate response to conventional therapy.

Astellas also intends to discuss the data with the regulatory authorities in other Asian countries to support further regulatory filings.