Sandoz Brings New Generic for Firazyr, Treating Acute HAE Attacks, to US

A new generic form of icatibant injection is now available in the United States to treat acute attacks of hereditary angioedema (HAE) in adults age 18 and older.

The medicine was licensed to Sandoz by Slayback Pharma for commercial use in the U.S., and comes packaged in prefilled, single-use syringes containing 30 mg of the active ingredient in a 3 mL dose.

It is equivalent to Takeda’s Firazyr in terms of effectiveness, safety, dosage, administration route, and quality.

This medication, approved in September, joins a growing list of generic icatibant versions in the U.S. Four icatibant generics were approved in 2020, including versions made by Cipla and by Fresenius Kabi.

“We are eager to see the positive effects of making generic icatibant available immediately to people living with this painful and disabling rare disease,” Keren Haruvi, president of Sandoz, said in a press release.

“This collaboration aligns with our goal to build our injectables portfolio and provide U.S. patients access to affordable generic medicines that work the same as brand-name products,” Haruvi added.

Icatibant stops potentially dangerous HAE attacks by blocking  interaction between the bradykinin protein and its receptor — specifically, the bradykinin B2 receptor.

This interaction would otherwise trigger a series of events leading blood vessels to grow wide and permeable, or leaky. Fluid from within the blood vessels can leak into surrounding tissue, causing the swelling that marks an HAE attack. Such attacks can be life-threatening when they occur in tissue near the airways, such as the larynx.

In the event of a laryngeal HAE attack, Sandoz recommends that patients seek immediate medical attention after using icatibant injection.

The most commonly reported side effects of the treatment have been skin reactions at the injection site. This occurred in nearly all patients (97%) during clinical trials. Other common side effects include fever, increased liver transaminase enzymes, dizziness, and a rash.

Sandoz did not include the generic’s list price in the release, but generics are typically less costly than brand-name medications.

“With our strong developmental capabilities and Sandoz’s industry-leading commercialization of its extensive portfolio of generic medicines, we couldn’t be more excited to collaborate with Sandoz and help people living with hereditary angioedema,” said Ted Smolenski, Slayback’s vice president of business development.