BioCryst’s HAE med Orladeyo wins NICE nod
NICE has recommended the treatment for people who have at least two attacks per month
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Tag: HAE
MHRA allows HAE patients early access to berotralstat
The oral, once-daily therapy is designed to prevent attacks and reduce burden of therapy
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Shire receives EU approval for Takhzyro
Shire has announced that the European Commission has approved its hereditary angioedema (HAE) drug Takhzyro.
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Shire’s lanadelumab shown to significantly cut HAE attacks
Shire says it presented data showing that its experimental drug lanadelumab provides a significant and clinically meaningful reduction of hereditary angioedema (HAE) attacks.
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Setback for Pharming’s bid to expand use of Ruconest
US regulators have turned down Pharming’s application to expand the approved uses of Ruconest to include prophylaxis in patients with hereditary angioedema (HAE).
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Shire’s HAE drug Takhzyro gets green light in the US
Shire’s Takhzyro has been approved in the US for the prevention of attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
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EU ready to review Shire’s lanadelumab for HAE
EU regulators have validated Shire’s application to market its experimental hereditary angioedema (HAE) drug lanadelumab, indicating that there is sufficient data to begin a priority review.
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Speedy EU review for Shire’s lanadelumab
European regulators will undertake an accelerated assessment of Shire’s hereditary angioedema (HAE) drug lanadelumab.
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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).
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Shire’s HAE drug Firazyr cleared for children
European regulators have approved a label extension for Shire’s Firazyr, broadening its use include adolescents and children aged two years and older with a particular type of HAE.
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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 angioedema (HAE) attacks in adolescent and adults
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