HAE – media

Shire Reports Regulatory Milestones for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for lanadelumab (SHP643) and also reports that Health Canada has completed screening and accepted the New Drug Submission (NDS) under Priority Review for this investigational compound.
- Source: Shire
- 617
- April 2, 2018
angioedema HAE lanadelumab New Approvals
Priority review for Shire’s HAE drug

US regulators are undertaking a speedy review of Shire’s lanadelumab (SHP643) for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema (HAE).
- Source: pharmatimes
- 790
- February 24, 2018
angioedema HAE Market Views
Shire Receives European Approval for Label Extension of FIRAZYR® (icatibant injection) for the Symptomatic Treatment of Acute HAE Attacks in Paediatric Patients

Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in serving patients with rare diseases, announced today that the European Commission (EC) has approved a label extension granting a new indication for FIRAZYR® (icatibant injection), broadening its use to adolescents and children aged 2 years and older, with hereditary angioedema (HAE) caused by C1-esterase-inhibitor (C1-INH) deficiency. FIRAZYR has been approved in the European Union (EU) since 2008 for symptomatic treatment of acute attacks of HAE in adults with C1-INH deficiency.
- Source: finance.yahoo
- 544
- October 30, 2017
EC FIRAZYR® HAE Shire
US nod for CSL Behring’s HAE prevention therapy

US regulators have approved CSL Behring’s Haegarda, the first C1 esterase inhibitor for subcutaneous administration to prevent hereditary (HAE) attacks in adolescent and adults.
- Source: pharmatimes
- 440
- June 23, 2017
HAE inhibitor New Approvals

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