BioCentury
ARTICLE | Clinical News

Rilonacept Regeneron rilonacept regulatory update

November 5, 2012 8:00 AM UTC

Regeneron voluntarily withdrew marketing authorization in the EU for Rilonacept Regeneron rilonacept to treat cryopyrin-associated periodic syndromes (CAPS) and said it will discontinue all development of rilonacept. The drug was approved for CAPS in the EU but was never marketed. Regeneron said it withdrew the MAA in the EU because "we decided in the wake of the FDA action on our gout application to discontinue further development of rilonacept." In July, FDA issued a complete response letter for an sBLA from Regeneron to prevent gout flares in patients initiating uric acid-lowering therapy (see BioCentury, Aug. 6). The drug is a recombinant protein with the heterodimeric IL-1 receptor linked to the Fc portion of human IgG. ...