EC Gives Thumbs Up to Jerini’s HAE Treatment
The European Commission (EC) has granted marketing authorization to Jerini’s Firazyr to treat hereditary angioedema (HAE), a potentially life-threatening genetic disease characterized by spontaneous and recurring attacks of tissue swelling.
The decision makes Firazyr (icatibant) the first product to be approved in the EU to treat HAE and comes roughly two weeks after Shire announced it would acquire Berlin-based Jerini for roughly $520 million.
According to Jerini, Shire is the best partner to pursue Firazyr’s EU launch and U.S. approval. Jerini received a not-approvable letter for the drug in April and said in June that it would submit a complete response to the letter in the next three to four months.
Jerini regained North American development and marketing rights to Firazyr last September after its U.S. affiliate and Kos Life Sciences terminated a licensing agreement for the drug. The termination came after Abbott, which purchased Kos in December 2006, determined the drug did not fit its core areas of therapeutic expertise.
Firazyr has been granted orphan drug status by the European Medicines Agency and the FDA.