5th November 2021
Celix Pharma is pleased to announce the approval of its first Marketing Authorisation (MA) - Pirfenidone Tablets by the MHRA.
Pirfenidone is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a rare, chronic and progressive lung disease caused by scarring in the lungs. There are currently no treatment options that stop or reverse IPF and the current treatment focuses on slowing the rate of scarring in the lungs and controlling symptoms. Pirfenidone is one of the few treatment options available for patients with IPF (1).
Commenting on this approval, Subir Kohli, Co-founder & CEO says, “We are extremely happy with Pirfenidone approval in the UK, first of our several products within the rare diseases space. An estimated 32,500 (2) people in the UK live with IPF. With the approval of this first generic alternative offering a reduced cost to the NHS, Pirfenidone will hopefully be available to a larger number of patients diagnosed with IPF.”
Shantreddy, Co-founder & COO added, “The approval of Pirfenidone is a regulatory milestone coming through in 8 months from the date of national submission to the MHRA. We are looking forward to launching this product in the UK market soon”.
1. Source: British Lung Foundation (https://www.blf.org.uk/)
2. Source: P272 Epidemiology of idiopathic pulmonary fibrosis in the UK: findings from the British lung foundation’s ‘respiratory health of the nation’ project. N Snell et al. (http://dx.doi.org/10.1136/thoraxjnl-2016-209333.415)
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