Biopharma Business

Shire has secured label expansion approval from the European Commission for its hereditary angioedema therapy Cinryze.

The European Commission (EC) has approved the label extension application, granting three new indications for Cinryze, which expands its coverage to treat children with hereditary angioedema (HAE).

Cinryze has been approved in Europe since 2011 for use in adult and adolescent HAE patients aged 12 years and over.

The product is now approved for routine prevention of angioedema attacks in children as young as six years with severe and recurrent attacks of HAE who are intolerant of or inadequately protected by oral preventative treatments or who are inadequately managed with repeated acute treatment.

It is also approved for the treatment and pre-procedure prevention of angioedema attacks in children as young as two years with HAE.

Cinryze was originally developed by ViroPharma, which was acquired by Shire in 2013 for $4.2bn.

Shire head of R&D Philip Vickers said: “This paediatric label expansion demonstrates our ongoing commitment to improving the lives of patients of all ages living with HAE.

“We believe the future of HAE means preventing attacks before they happen, and are proud to now be able to offer the first long-term preventative treatment for paediatric patients. As we expand our HAE portfolio, we remain focused on innovative solutions that fulfil unmet needs for people worldwide living with this rare disease.”

Cinryze will be available for use in paediatric patients later in 2017 across Member States of the European Union (EU), as well the European Economic Area (EEA) in which Shire currently has a licence in the adult and adolescent population.

The active substance in Cinryze is C1-INH, which can restore functional C1-INH levels in patients with HAE.