New Icatibant Injectable Available Soon in Sweden, Norway for HAE

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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Newbury Pharmaceuticals is launching its injectable therapy of icatibant, the active agent of Firazyr, in Sweden and Norway to treat acute attacks in people with hereditary angioedema (HAE).

“Making Icatibant Newbury available in Sweden and Norway is an important milestone to Newbury as we see the fruits of the seeds sown,” Lars Minor, Newbury’s CEO, said in a press release.

The medication comes in the form of a 3 mL, pre-filled, single-use syringe that’s administered under the skin (subcutaneously) in the abdomen or stomach. After training with a healthcare professional, patients can self-administer the medication as needed.

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Icatibant was designed to block the activity of a protein called bradykinin — a signaling molecule that, when bound to its receptor (called bradykinin B2 receptor), leads to the widening of blood vessels, making them more permeable. As a result of this permeability, fluid can leak out and accumulate in tissues, causing the swelling that characterizes HAE.

Shire, now part of Takeda, was the original developer of Firazyr. Several generic forms of the medication are available, including the ones manufactured by Cipla, Fresenius Kabi USA, Jiangsu Hansoh Pharmaceutical Group, and Teva Pharmaceuticals.

Data from several Phase 3 clinical trials showed that icatibant was effective for acute attacks in people with HAE. Treatment was deemed to be safe, with injection site reactions among the common adverse events reported in trials. These reactions were usually mild-to-moderate in intensity, and eventually disappeared with time.

Newbury is a Swedish company specialized in providing patients and healthcare providers access to medications in the Scandinavian market. Founded in 2020, Newbury in-licenses (where the financial burden of product development is shared with other companies) the proprietary rights of treatments, which helps speed their registration and commercialization. The company focuses mainly on cancer, neurological, and rare diseases.

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This is the first Newbury product that was made available to patients and doctors in Sweden and Norway. With a total of 27 in-license medications in its portfolio, the company expects to start marketing other products this year.

“We expect to see more products being launched this year and to harvest some of these fruits during second half of 2022 and 2023 with an ambition of growing the business continuously,” said Minor.

Icatibant Newbury will be marketed once trading agreements are finalized.