Adalvo submits generic dossier applications for Icatibant pre-filled syringe

16 July 2020

Adalvo today announces that it has submitted filings for generic dossier applications with the European Medicines Agency, seeking approval to market an Icatibant pre-filled syringe. Based on available information, Adalvo believes it is in the first wave of applicants to submit its filing within the European Union.

Adalvo’s product is a generic version of Shire Pharmaceutical’s (now Takeda) Firazyr® injection, which is indicated for the treatment of acute attacks of hereditary angioedema. The product has been co-developed with a US-based pharmaceutical company in an exclusive licensing collaboration global markets (excl. US and China).

In 2019, Firazyr® had global sales of approximately $400 million, according to IQVIA.

A fast-growing portfolio

With its global partners, Adalvo has built a dynamic high-value portfolio of more than 60 products and today’s announcement further enhances the company’s peptide portfolio, which currently includes several products focused on rare diseases and diabetes. Adalvo currently serves patients through commercial partnerships in more than 60 countries around the world.

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