BioCentury
ARTICLE | Company News

Pharming tries again with Ruconest BLA

April 18, 2013 12:28 AM UTC

Pharming Group N.V. (Euronext:PHARM) and partner Santarus Inc. (NASDAQ:SNTS) said Pharming submitted a BLA to FDA for Ruconest conestat alfa to treat acute attacks of hereditary angioedema (HAE). FDA refused to file a BLA for the product in 2011. The new BLA submission contains data from the Phase III Study 1310 trial, which FDA had requested when it refused to file the application. The BLA also now includes data for an additional 226 administrations of Ruconest and from 46 additional HAE patients.

Pharming also amended the protocol of Study 1310 to address issues raised by FDA when it refused to file the original BLA. Last year, Pharming and Santarus reported data from Study 1310 showing a single IV infusion of Ruconest met the primary endpoint of reducing median time to beginning of symptom relief vs. placebo (see BioCentury Extra, Nov. 7, 2012). ...