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/)
About Celix Pharma Ltd
Celix Pharma is a London-based generic pharmaceutical company founded in 2020 with an overarching goal to bring high quality, affordable, generic medicines with a sustainable supply chain to the UK. Celix Pharma focuses on bridging gaps in the market by identifying product opportunities arising from complexities in development and/or manufacturing, addressing supply disruptions and future patent expiries with a portfolio spanning generics, value-added generics, and hospital specialty products. Celix Pharma’s business model is built around creating a commercially led, customer-focused organization supported with strategic partnerships in R&D and manufacturing.
For more information, visit www.celixpharma.com