Hereditary Angioedema

Lanadelumab may be an effective prophylactic treatment for hereditary angioedema

December 07, 2018

The most common adverse reactions associated with lanadelumab treatment were injection site reactions and headache.

Lanadelumab Examined for Attack Rate in Hereditary Angioedema

November 28, 2018

During the treatment period, the mean number of attacks per month was 1.97 for placebo and 0.48, 0.53, and 0.26 for the lanadelumab groups, respectively. The mean differences in the attack rate per month compared with placebo were −1.49, −1.44, and −1.71, respectively.

Lanadelumab Well-Tolerated in Hereditary Angioedema

November 16, 2018

Patients with hereditary angioedema who received lanadelumab exhibited few cases of hypersensitivity and had low immunogenicity.

FDA Requests Another Clinical Trial for Ruconest in HAE Prophylaxis

By September 21, 2018

The Company filed the sBLA last November following FDA feedback on two completed Phase 2 trials of Ruconest for prophylaxis of HAE attacks.

Single-Administration Treatment for Hereditary Angioedema Gets Orphan Drug Status

By August 28, 2018

ADVM-053 is being developed as a single‑administration treatment that could potentially provide sustained levels of the C1 esterase inhibitor protein, which may prevent breakthrough angioedema attacks.

First-of-its-Kind Therapy Approved to Prevent Hereditary Angioedema Attacks

By August 24, 2018

The approval was based on data from 4 clinical trials, including the 26-week Phase 3 HELP (Hereditary Angioedema Long-Term Prophylaxis) study that enrolled 125 patients with HAE aged ≥12 years.

FDA Fast-Tracks Plasma Kallikrein Inhibitor for Angioedema Attacks in HAE

By August 08, 2018

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.

Plasma Kallikrein Inhibitor Cuts Rate of Hereditary Angioedema Attacks

July 26, 2018

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

By June 22, 2018

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

By February 26, 2018

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

By August 07, 2017

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

By July 25, 2017

"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

By July 25, 2017

Haegarda reduced the number of HAE attacks by a median of 95% vs. placebo

New Treatment Option for Hereditary Angioedema FDA-Approved

By June 23, 2017

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

By May 30, 2017

Upper airway angioedema, while rare, is a potentially life-threatening side effect of ACEIs.

CSL830 for Prevention of Hereditary Angioedema Attacks

By March 23, 2017

Longhurst, Hilary, et al. "Prevention of Hereditary Angioedema Attacks with a Subcutaneous C1 Inhibitor"

Subcutaneous C1 Inhibitor May Reduce Angioedema Attacks

March 23, 2017

The study results showed that compared with placebo, both doses of CSL830 reduced the rate of attacks of hereditary angioedema

Pediatric Treatment for Hereditary Angioedema Gets FDA Approval

By July 18, 2016

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.

Treatment Options for Managing ACEI-Induced Angioedema

By June 03, 2016

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.

Hereditary Angioedema Tx Now a Breakthrough Therapy

By July 07, 2015

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigation of DX-2930 (Dyax) for hereditary angioedema (HAE).

First-in-Class Drug Launched for Hereditary Angioedema

November 03, 2014

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).

Ruconest Approved for Acute Angioedema Attacks in HAE

July 17, 2014

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).

Kalbitor Inj Indication Expanded to Pediatric Patients

April 03, 2014

Dyax announced that the FDA has expanded the indication for Kalbitor (ecallantide) to include patients >12 years old.

Ruconest BLA Under Review for Acute Hereditary Angioedema

June 18, 2013

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.

rhC1INH Cuts Attack Frequency in Hereditary Angioedema

November 08, 2012

For patients with hereditary angioedema (HAE), weekly administration of recombinant C1INH (rhC1INH) is well tolerated and is associated with a reduction in attack frequency.

Phase 3 Trial Update of Ruconest for Acute Hereditary Angioedema

November 07, 2012

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.