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).
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.
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.
The human plasma-derived, purified, pasteurized, lyophilized concentrate is derived from large pools of human plasma from U.S. donors.
Longhurst, Hilary, et al. "Prevention of Hereditary Angioedema Attacks with a Subcutaneous C1 Inhibitor"
CSL Behring announced that the Food and Drug Administration (FDA) has approved the use of Berinert (C1 esterase inhibitor [human]) for the treatment of hereditary angioedema (HAE) attacks in pediatric patients.
For the management of angiotensin-converting enzyme inhibitor (ACEI)-induced angioedema, use of fresh frozen plasma and complement 1 esterase (C1) inhibitor appear to be safe and effective whereas ecallantide should be avoided, a study published in the American Journal of Health-System Pharmacy concluded.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigation of DX-2930 (Dyax) for hereditary angioedema (HAE).
Salix and Pharming Group announced the launch of Ruconest (C1 esterase inhibitor [recombinant]) injection for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).
Salix and Pharming Group NV announced that the FDA has approved Ruconest (C1 Esterase Inhibitor [Recombinant]) for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE).
The FDA has accepted for review Santarus and Pharming's Biologics License Application for Ruconest (INN conestat alfa) 50 IU/KG, a recombinant human C1 esterase inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema.
For patients with hereditary angioedema (HAE), weekly administration of recombinant C1INH (rhC1INH) is well tolerated and is associated with a reduction in attack frequency.
Santarus and Pharming Group NV announced that their Phase 3 clinical study of Ruconest (recombinant human C1 esterase inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met its primary endpoint.