Shire has welcomed the news that Firazyr, a treatment for acute attacks of hereditary angioedema developed by Germany’s Jerini, which is in the process of being taken over by the UK firm, has been given the green light by regulators in Europe.

The European Commission’s approval allows Jerini to market Firazyr (icatibant), its lead compound, making it the first product to be approved in all European Union member states for the treatment of HAE. The latter is a debilitating and potentially life-threatening genetic disease, Shire noted, “characterised by spontaneous and recurring attacks of oedema”.

Firazyr, which has been in development since 2001, works by blocking the B2 receptor as an antagonist to the peptide-hormone bradykinin. It has orphan drug status in Europe and the USA, which should give it market exclusivity for ten and seven years, respectively.

Sylvie Gregoire, president of Shire Human Genetic Therapies, said that the European approval is “an important step in bringing this first-in-class orphan treatment to patients who suffer from HAE attacks”. She added that the firm is looking forward to the completion of the transaction with Jerini, expected around the fourth quarter, “which will enable us to work together and ultimately build Firazyr into a global gold standard treatment.”

Earlier this month, Shire announced that it would pay 328 million euros to buy Jerini, which represented a 199% premium over the latter’s average stock price during the three months prior to the offer.