Cipla Given FDA Approval for Icatibant, Generic Version of Firazyr
Cipla has received final approval from the U.S. Food and Drug Administration (FDA) for a generic version of Firazyr (icatibant injection), an approved treatment for acute attacks in adults with hereditary angioedema (HAE).
The company announced the FDA approval of its abbreviated new drug application for icatibant injectable in a press release. Cipla’s generic form of the medication will be available in a pre-filled 30 mg/3 mL syringe. It is designed to be administered under-the-skin (subcutaneously) in the abdominal area.
The active ingredient in Firazyr is icatibant. Cipla’s new generic form has the same active ingredient. Like other generic medications, it was created to be equivalent to the reference product — in this case, Shire’s Firazyr — in terms of its effectiveness, safety, dosage, administration route, quality, and performance.
Icatibant works by blocking the activity of a protein called bradykinin. Bradykinin is a signaling molecule that, upon binding to its receptor, causes blood vessels to widen and grow more permeable. This allows fluid to leak out and build up in tissue — swelling.
Icatibant is a selective bradykinin B2 receptor antagonist, which means it blocks the receptor to which bradykinin usually binds — the bradykinin B2 receptor. By blocking this receptor, icatibant interrupts the bradykinin signaling that normally would lead to swelling.
According to IQVIA, sales of icatibant products in the U.S. — including Firazyr and approved generic equivalents — totaled approximately $270 million for the 12-month period ending in May.