27th April 2022 

Celix Pharma is pleased to announce the grant of its Marketing Authorisation (MA) for Icatibant 30mg Solution for Injection in a pre-filled syringe by the MHRA.  

Icatibant is indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older. HAE is a rare inherited disorder characterized by recurrent episodes of the accumulation of fluids outside of the blood vessels, blocking the normal flow of blood or lymphatic fluid and causing rapid swelling of tissues in the hands, feet, limbs, face, intestinal tract, or airway (1). As a pre-filled syringe stored at ambient conditions, patients can self-administer this emergency medicine on-the-go.   

Commenting on this approval, Subir Kohli, Co-founder & CEO said, “Celix hits another milestone today with the approval of Icatibant Injection. This is our first injectable product approval and the second in the rare diseases space. We are looking forward to bringing this product to market soon”. 

Shantreddy, Co-founder & COO added “Icatibant is a synthetic decapeptide in a drug-device combination. We are thrilled to have successfully navigated the challenging regulatory pathway for this complex injectable product.”   

1. Source: National Organisation for Rare Disorders (https://rarediseases.org/rare-diseases/hereditary-angioedema/)