Posted from: Friday, August 09, 2019 - 03:05 PM - Present

Firazyr Generic Approved

July 15, 2019 – The U.S. FDA has approved Teva Pharmaceuticals’ generic for Takeda’s Firazyr® (icatibant injection). The product is indicated to treat acute attacks of hereditary angioedema (HAE) in patients 18 years of age and older.

A rare genetic condition, HAE occurs in anywhere from 1-in-10,000 to 1-in-50,000 people worldwide. It is caused by a defect in the gene that controls C1 Inhibitor, a blood protein, the lack of which leads to potentially life-threatening episodes of swelling in various parts of the body. These attacks can cause severe pain and interfere with basic functions such as breathing. Without treatment, the mortality rate of HAE due to swelling in the throat can be as high as 30%. Attacks can be triggered by a variety of circumstances, including physical activity, emotional stress, physical trauma, and medical procedures.

Icatibant injection should be used upon recognition of an HAE attack. The recommended dosing is 30mg injected subcutaneously in the abdominal area, with the option to administer up to two additional 30mg injections at least six hours apart if the patient’s response is inadequate or symptoms recur. Patients or caregivers can administer icatibant injection at home once trained in proper procedure by a healthcare provider. Each prefilled syringe delivers 30mg of icatibant.

Teva’s generic is available at an average wholesale price (AWP) of $6,099.91 per syringe, compared to $13,376.99 for the brand name product.

Last Updated Thursday, October 17, 2019 - 07:17 AM.