The FDA has approved Shire’s Firazyr (icatibant injection), the first self-administered treatment of acute attacks of hereditary angioedema (HAE) in the US.
The portable, pre-filled syringe means that the unpredictability of HAE attacks are easier to handle for patients suffering from the disease.
Timothy Craig, Professor of Medicine & Paediatrics, Penn State Hershey Medical Center, Pennsylvania, said: “Until now, HAE patients faced challenges gaining rapid access to acute treatment such as the need to travel to the physician’s office or hospital”.
But following initial injection training, the treatment can be self-administered by any patient and should be stored at room temperature.
Janet Long, US HAE Association Executive Vice President, stated: “With this approval, patients have an important new option to treat HAE attacks.”
The FDA’s approval was based on results collated from three double-blind, randomised, controlled clinical trials involving 223 patients.
HAE is a rare genetic disease characterised by recurrent and often painful episodes of acute swelling which can be life-threatening. The swelling can affect any part of the body but most commonly occur in the face, gastrointestinal tract, extremities or genitals.
The disease is caused by low levels of C1 esterase inhibitor, which can lead to elevated plasma levels of bradykinin, thought to be responsible for HAE symptoms. Signs and symptoms of HAE do not respond to standard treatments for allergic angioedema such as epinephrine, corticosteroids, and antihistamines.
Firazyr is now approved in 38 countries, including the European Union and the US for the treatment of acute attacks of HAE in adults.