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Cipla Given FDA Approval for Icatibant, Generic Version of Firazyr

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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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.

Firazyr was approved as a HAE treatment for acute attacks in adults (18 and older) by the FDA in 2011. The treatment was developed by Shire, which is now part of Takeda Pharmaceuticals.

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.

In multiple Phase 3 clinical trials, icatibant has been demonstrated to be effective in the treatment of acute attacks in people with HAE. The medication also has been shown to have a good safety profile; the most common adverse events (side effects) reported in trials were injection site reactions, which were usually mild-to-moderate in intensity and went away with time.

In addition to Cipla’s newly approved version, other generic versions of Firazyr are available: one by Fresenius Kabi USA, one by Jiangsu Hansoh Pharmaceutical Group, and one by Teva Pharmaceuticals.

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.

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