CSL Behring wins approval for first subcutaneous HAE therapy

Haegarda (C1 esterase inhibitor (human), a therapy for hereditary angioedema (HAE) from biotech firm CSL Behring, has been approved by the US Food and Drug Administration.

The rare genetic disorder, which is caused by insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the USA.

The US subsidiary of Australia's CSL Limited (ASX: CSL) developed Haegarda as the first C1-esterase inhibitor for subcutaneous administration, to prevent HAE attacks in adolescent and adult patients.

CSL’s share price rose almost 2% following the news.

"The approval of Haegarda provides a new treatment option for adolescents and adults with hereditary angioedema," said Peter Marks, director of the FDA’s biologics center.

"The subcutaneous formulation allows patients to administer the product at home to help prevent attacks."

The efficacy of Haegarda was demonstrated in a 16 week trial, during which patients experienced a significantly reduced number of HAE attacks during treatment.

The most common side effects included injection site reactions, allergic reactions, swelling of the nasal passages and throat, and dizziness.