News Focus
News Focus
icon url

DewDiligence

03/20/11 7:33 AM

#116682 RE: genisi #116681

In the EU, Shire's Firazyr label was recently amended to include self administration as well, so it's the first and only SubQ self administered agent for acute HAE, an advantage that is hard to compete with. If approved with a similar label by the FDA, I expect it to gain a big share in the acute market. This of course will hurt Dyax's Kalbitor and CSL Behring's Berinert but not VPHM’s Cinryze.

Sub-q administration certainly beats having to leave an IV port in the arm, which increases the risk of infection.
icon url

DewDiligence

01/03/12 8:56 PM

#134266 RE: genisi #116681

FDA approves self-administration label expansion for acute use of Berinert:

http://finance.yahoo.com/news/CSL-Behring-Receives-FDA-prnews-695264075.html?x=0

Berinert has been on the US market since Oct 2009 (#msg-42409618).
icon url

mcbio

04/27/13 12:58 AM

#160390 RE: genisi #116681

DYAX

In the EU, Shire's Firazyr label was recently amended to include self administration as well, so it's the first and only SubQ self administered agent for acute HAE, an advantage that is hard to compete with. If approved with a similar label by the FDA, I expect it to gain a big share in the acute market. This of course will hurt Dyax's Kalbitor and CSL Behring's Berinert but not VPHM’s Cinryze.

What do you make of DYAX's DX-2930, which is set to enter the clinic middle of this year: http://www.dyax.com/angioedema-portfolio/research-development.html ? For more detail, see: http://investor.dyax.com/releasedetail.cfm?ReleaseID=742676 . It's basically a self-administered subQ, long-acting, prophylactic treatment for HAE. Do you see this as a drug that, if successful, could turn DYAX's HAE fortunes around?