Sorry, maar er staat natuurlijk veel meer BELANGRIJK(er)S in.
b.v dat Firazyr een groei heeft gemaakt van 82% $6,1milj naar 11,1
de concurentie: FIRAZYR competes in Europe with CSL Behring’s BERINERT P, a human plasma-derived C1-esterase inhibitor (C1-INH) product, and with Pharming Group N.V.’s RUCONEST (a recombinant version of C1-INH), which has recently received EMA approval and will be launched in Europe by Swedish Orphan Biovitrum. If approved in the US, FIRAZYR will compete with BERINERT and with Dyax Corporation’s KALBITOR, a plasma kallikrein inhibitor. FIRAZYR will also compete indirectly with Viropharma, Inc.’s CINRYZE, a plasma-derived CI-INH product approved in the US for prophylaxis of HAE attacks.
Firazyr voor gebruik in de VS:
Prior to its acquisition by Shire, Jerini AG (“Jerini”) received a not approvable letter for FIRAZYR for use in the US from the FDA in April 2008. Shire agreed with the FDA that an additional clinical study would be required before approval could be considered and that a complete response to the not approvable letter would be filed after completion of this study. Shire has now completed a Phase 3 study in patients with acute attacks of HAE, known as the FAST-3 trial, and anticipates submitting a complete response to the FDA in early 2011.
Enz. enz.