New Generic Version of Firazyr Now Available in US to Treat Acute HAE Attacks

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by Forest Ray PhD |

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Icatibant injection, a generic form of Firazyr from Fresenius Kabi, is now available to adults in the United States for the treatment of acute attacks of hereditary angioedema (HAE), the company announced.

“For people with HAE, an acute attack can occur anywhere, at any time and can be life-threatening,” John Ducker, president and CEO of Fresenius Kabi USA, said in a press release.

Simply called icatibant injection, the treatment is the fourth generic form of icatibant available in the U.S., joining versions made by Cipla, Teva Pharmaceuticals, and the Jiangsu Hansoh Pharmaceutical Group.

It is a “cost-effective alternative to treat acute attacks” of HAE, the company said.

The treatment comes as a 3 mL, pre-filled, single-use syringe designed to be administered under the skin (subcutaneously) in the abdominal area. After training with a healthcare professional, patients can self-administer the medication as needed, in or out of home.

Icatibant stops fluid from leaking out of blood vessels and into surrounding tissue by preventing the bradykinin protein from connecting to its receptor — the bradykinin B2 receptor. This interaction would otherwise send signals to cells that result in blood vessels both widening and growing more permeable, or leaky.

The swelling from such HAE acute attacks can occur anywhere on the body. These attacks can become life-threatening when they occur near airways, such as in the larynx.

In the event of a laryngeal attack, Fresenius Kabi recommends immediately seeking emergency room treatment after using icatibant injection.

To go along with the new generic treatment, Fresenius Kabi also launched a comprehensive patient care program called KabiCare. Through this program, eligible patients will have access to live case managers, co-pay assistance, and self-injection training designed to make icatibant inject easier to use.

Patients also can obtain pharmaceutical samples through KabiCare, to bridge any gap in therapy resulting from a delay in healthcare coverage. The company expects to support future products through KabiCare, as they become available.

“Fresenius Kabi wants to be a valuable resource for patients and their care teams, which is why we are offering a patient support program for the first time,” Ducker said.

The original medication, Firazyr — developed by Shire, now part of Takeda Pharmaceuticals – was first approved in 2011 for the treatment of acute HAE attacks in patients ages 18 and older.

Fresenius Kabi’s icatibant injection and other generic versions contain the same active ingredient, and therefore have similar safety, dosage, administration route, quality, and performance. However, these generic versions have much lower price tags.