Adalvo’s Firazyr Generic on Track to Becoming Available in EU

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by Patricia Inacio PhD |

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Adalvo has completed a mandatory requirement for a marketing authorization in the European Union for its generic version of Firazyr (icatibant injection), which is approved for acute attacks in adults with hereditary angioedema (HAE), the company has announced.

The successful closure of the decentralized procedure came more than a year after Adalvo submitted applications to the European Medicines Agency seeking approval to commercialize its icatibant pre-filled syringe.

The decentralized procedure is used by companies seeking marketing authorization for a medicine that has not yet been authorized in the E.U. or is not eligible to be authorized under its centralized procedure. Companies may use this procedure to obtain authorization to market a treatment in several E.U. member states at the same time.

Icatibant, developed in collaboration with AmbioPharm, is a more affordable version of Firazyr, allowing for broader access to the therapy.

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Firazyr (icatibant injection)

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Firazyr, originally developed by Shire, now part of Takeda Pharmaceuticals, was previously approved as a treatment for acute HAE attacks in the U.S. and Europe.

Icatibant is the same active ingredient in Firazyr and in Adalvo’s new generic form. Like other generic medications, Adalvo’s medication was created to have an equivalent profile to the reference product — in this case, Shire’s Firazyr — in terms of its effectiveness, safety, dosage, administration route, quality, and performance.

HAE is characterized by an accumulation of bradykinin, a pro-inflammatory molecule that causes blood vessels to dilate and become more permeable. This allows fluid to leak out and accumulate in tissues, ultimately causing swelling.

Icatibant acts by blocking the receptor, called bradykinin B2, to which bradykinin usually binds. This interrupts the bradykinin signaling cascade that normally would lead to swelling.

Data from several Phase 3 clinical trials showed that icatibant was safe and effective at treating acute attacks in people with HAE. The most common adverse events reported across different trials were injection-site reactions, but these were usually mild-to-moderate in intensity and resolved with time.

Other generic versions of Firazyr are available, including ones manufactured by Cipla, Fresenius Kabi USA, Jiangsu Hansoh Pharmaceutical Group, and Teva Pharmaceuticals.

Worldwide Firazyr sales amounted to approximately $330 million last year, according to IQVIA, a healthcare analytics company.