SOBI seeks Kineret approval for CAPS

Swedish Orphan Biovitrum AB (SSE:SOBI) submitted a regulatory application to EMA to expand the label for Kineret anakinra to include cryopyrin-associated periodic syndromes (CAPS). Kineret is also under Priority Review in the U.S. for neonatal onset multisystem inflammatory disease (NOMID), which is the most severe form of CAPS. The PDUFA date is Dec. 25. Swedish Orphan, which markets the IL-1 receptor antagonist to treat rheumatoid arthritis, has exclusive, worldwide rights to Kineret from Amgen Inc. (NASDAQ:AMGN) for RA and undisclosed Orphan indications. Swedish Orphan was up SEK0.30 to SEK31.40 on Monday. Amgen was up $0.86 to $85.40.

Kineret would compete with Ilaris canakinumab, an IL-1 blocker from Novartis AG (NYSE:NVS; SIX:NOVN) approved in more than 60 countries to treat CAPS. ...