The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. It's already approved to treat one autoimmune disease, and bring in about $650 million a year. The company is now pursuing an indication for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare neurological disorder in which patients suffer from weakness and impaired sensory function in the legs and arms. Gamunex previously received fast track and orphan drug status.
- here's the Talecris release [1]
- read this report [2] for more
Related Article:
Talecris backers design a $1 billion IPO [3]
Links:
[1] http://www.fiercebiotech.com/press-releases/fda-grants-priority-review-talecris-biotherapeuticss-gamunex-treatment-neurological-d
[2] http://www.bizjournals.com/triangle/stories/2008/05/05/daily41.html
[3] http://www.fiercebiotech.com/story/talecris-backers-design-1-billion-ipo/2007-07-30