Shire plc, an Irish drug company with a big presence in Massachusetts, said it received regulatory approval to market a new treatment for a rare genetic disease in the United States.
The drug is Firazyr, and it is aimed at adults with hereditary angioedema, or HAE, which is characterized by recurrent and often painful episodes of acute swelling. It can be life-threatening.
In a press release, Shire said that the Food and Drug Administration has granted marketing approval for Firazyr as an HAE treatment for patients 18 years of age and older.
HAE treatments currently on the US market can only be administered in a hospital or a doctor’s office, Shire said; what sets Firayzr apart is that it can be stored at room temperature and self-injected by a patient.
Getting a favorable review from the FDA means that Firazyr has been approved in 38 countries, Shire said.
One of Shire’s specialties is developing treatments for rare diseases. The company’s rare-disease unit is based in Lexington. Shire has about 1,500 employees in Massachusetts.