BRIEF—Astellas to pursue Asian filings for novel second-line RA therapy

Japan’s Astellas Pharma says two Phase III trials - RAJ3 and RAJ4 - of ASP015K (peficitinib hydrobromide) in rheumatoid arthritis met their primary endpoints.

The therapy showed superiority over placebo at week 12, with an improvement of at least 20% in various rheumatoid arthritis endpoints.

The firm says that a safety analysis reveals a profile consistent with prior clinical trials for the therapy.

Astellas says it intends to discuss the data with the regulatory authorities in Japan and other Asian countries to support a regulatory filing for a new therapeutic option for patients with an inadequate response to existing therapies.