Berinert Claims Another Part Of The HAE Orphan Market, But May Leave Room
FDA's approval of CSL Behring's Berinert for treatment of acute attacks of hereditary angioedema specifically mentions only two types of attacks. By approving the C1 esterase inhibitor with a targeted indication, the agency could be leaving open a window in the orphan exclusivity for another approval
You may also be interested in...
Program provides commercially insured patients with up to $12,000 a year in eligible expenses for C1 esterase inhibitor Berinert, used to treat the rare disease hereditary angioedema.
With four drugs in the space, hereditary angioedema is an unusually well-served orphan disease. But the rare condition still has no clear path for efficacy assessment.
Shire reports positive phase III results for its HAE drug and may file a complete response in the next few months.