Sunday , June 25 2017
Home / Hereditary Angioedema

Hereditary Angioedema

Shire’s Investigational Hereditary Angioedema Drug Demonstrates Positive Results in Late-Stage Trial

Lexington, MA – May 18, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, announces positive topline Phase 3 results for the HELP™ study, a global, multi-center, randomized, double-blind placebo-controlled parallel group trial that evaluated the efficacy and safety of subcutaneously administered lanadelumab versus placebo …

Read More »

CSL Behring’s CSL830 Prevents Hereditary Angioedema Attacks in Late-Stage Study

Median reduction in hereditary angioedema (HAE) attack rate relative to placebo was 95% at the highest dose studied Data show up to 40% of HAE patients were free from attacks throughout the study In the clinical study, CSL830 met the primary endpoint for preventing HAE attacks Global biotherapeutics leader CSL …

Read More »

FDA Accepts CSL’s BLA for First Subcutaneous Prophylactic Therapy to Prevent HAE Attacks

KING OF PRUSSIA, Pa., Aug. 30, 2016 /PRNewswire/ — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its low-volume subcutaneous (SC) C1-Esterase Inhibitor (C1-INH) Human replacement therapy, CSL830, as prophylaxis to prevent Hereditary Angioedema (HAE) …

Read More »

FDA Expands Approval of CSL Behring’s Berinert for Treatment of HAE in Children Under 12

KING OF PRUSSIA, Pa., July 18, 2016 /PRNewswire/ — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Berinert [C1 Esterase Inhibitor (Human)], its therapy for treating Hereditary Angioedema (HAE) attacks, for use in pediatric patients.  This expands the use of Berinert …

Read More »

Shire to Acquire Dyax for up to $6.5 Billion

Shire plc (LSE: SHP, NASDAQ: SHPG) and Dyax Corp. (NASDAQ: DYAX) today announced that Shire will acquire Dyax for $37.30 in cash per Dyax share, for aggregate upfront consideration of approximately $5.9 billion. Dyax shareholders may receive additional value through a non-tradable contingent value right (CVR) that will pay $4.00 …

Read More »

Prime Therapeutics’ Studies Assess Costs in Cystic Fibrosis and Hereditary Angioedema

Today, pharmacy benefit manager Prime Therapeutics LLC announced findings from two separate studies regarding the costs associated with treatment for cystic fibrosis (CF) and hereditary angioedema (HAE). According to findings from new research by Prime, ground-breaking new CF drugs that target the gene mutations causing the disease will significantly increase …

Read More »