Tag Archives: Hereditary angioedema

August, 2018

24 August
FDA Approves Shire’s Takhzyro, a First-of-its-Kind mAb Preventive Treatment for Hereditary Angioedema

Dublin, Ireland – August 23, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that following priority review, the U.S. Food and Drug Administration (FDA) has approved TAKHZYRO™ (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 …
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21 June
FDA Approves Expanded Label for Shire’s Cinryze for Prevention of Attacks in Pediatric Hereditary Angioedema

Dublin, Ireland – Thursday, June 21, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for CINRYZE® (C1 esterase inhibitor [human]), making it available to help prevent angioedema attacks …
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21 July
CSL Behring’s Haegarda Receives Orphan-Drug Exclusivity for Prevention of Hereditary Angioedema Attacks

KING OF PRUSSIA, Pa., July 21, 2017 /PRNewswire/ — Global biotherapeutics leader CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted the Company seven years of orphan-drug exclusivity for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only subcutaneous treatment option for prevention of …
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26 June
FDA Approves CSL Behring’s Haegarda for Prevention of Hereditary Angioedema Attacks

Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only subcutaneous therapy indicated for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. HAE is a rare, genetic, and …
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18 May
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 …
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23 March
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 …
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30 August
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) …
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19 July
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 …
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2 November
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 …
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6 April
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 …
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