News

EMA grants PRIME designation to NTLA-2002 gene-editing therapy

The European Medicines Agency (EMA) has granted priority medicines (PRIME) designation to Intellia Therapeutics’ NTLA-2002, an experimental gene-editing therapy to prevent swelling attacks in people with hereditary angioedema (HAE). A PRIME designation supports the development of experimental therapies that address unmet medical needs. Eligibility for this status is…

Acquired angioedema can be treated with off-label use of HAE therapies

On-demand and preventive treatment with either icatibant injection or C1 inhibitor (C1-INH) concentrates — which are approved for hereditary angioedema (HAE) — also can help people with acquired angioedema keep swelling under control, according to a small study in Germany. People severely affected with acquired angioedema and no “underlying condition…

EU panel recommends Takhzyro for children as young as 2

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended the approval of Takhzyro (lanadelumab) for the routine prevention of hereditary angioedema (HAE) attacks in children starting at age 2. Based on a positive opinion from the CHMP, the European…

ACE inhibitor ID’d as likely cause of angioedema after surgery: Case

A 46-year-old man developed delayed angioedema following surgery — with his tongue swelling significantly four hours later — that likely was triggered by the use of an ACE or angiotensin-converting enzyme inhibitor to treat his high blood pressure, according to a new case report. Due to rapid evaluation by…

Orladeyo recommended for reimbursement in Québec

The Institut national d’excellence en santé et services sociaux (INESSS) has recommended that BioCryst Pharmaceuticals’ Orladeyo (berotralstat) be reimbursed by public health plans for eligible adults and adolescents 12 and older with hereditary angioedema (HAE) in the Canadian province of Québec. A similar recommendation was made earlier…