FDA Fast-Tracks Plasma Kallikrein Inhibitor for Angioedema Attacks in HAE
The Company is currently conducting a Phase 3 trial (APeX-2) and a long-term safety study (APeX-S) evaluating 2 doses of the treatment.
Hereditary Angioedema
Plasma Kallikrein Inhibitor Cuts Rate of Hereditary Angioedema Attacks
The most commonly reported adverse events were gastrointestinal adverse events, mainly grade 1, especially in the 2 highest BCX7353-dose groups.
Cinryze Approved for Pediatric Patients With Hereditary Angioedema
The approval was based on data from a randomized, single-blind, multicenter, dose-ranging, crossover study which evaluated the safety and efficacy of Cinryze in 12 pediatric patients (7 to 11 years old).
BLA for Novel Hereditary Angioedema Treatment Accepted by FDA
Results found that those who received a subcutaneous administration of 300mg lanadelumab once every 2 weeks had an 87% reduction in mean frequency of HAE attacks.
Angioedema Risk Assessed for Aliskiren vs. Other Antihypertensives
The case-control analysis found no significant difference in the angioedema risk for aliskiren monotherapy and fixed-dose combination compared to BBs with adjusted odds ratio of 0.99 (95% CI, 0.45-2.20) and 1.06 (0.40-2.76), respectively.
Angioedema Risk Evaluated for Levetiracetam Versus Phenytoin
“The results suggest that levetiracetam has the same or lower risk for angioedema than phenytoin,” wrote the researchers.
Haegarda Available for Routine Prophylaxis of Hereditary Angioedema Attacks
Haegarda reduced the number of HAE attacks by a median of 95% vs. placebo
New Treatment Option for Hereditary Angioedema FDA-Approved
The human plasma-derived, purified, pasteurized, lyophilized concentrate is derived from large pools of human plasma from U.S. donors.
Icatibant Evaluated for ACE Inhibitor-Induced Angioedema
Upper airway angioedema, while rare, is a potentially life-threatening side effect of ACEIs.
CSL830 for Prevention of Hereditary Angioedema Attacks
Longhurst, Hilary, et al. “Prevention of Hereditary Angioedema Attacks with a Subcutaneous C1 Inhibitor”
