Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults
Following a 15 May 2014, meeting with FDA, Shire plc, the global specialty biopharmaceutical company, announces that it intends to submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in the first-quarter 2015, as it completes remaining chemistry and manufacturing work. In parallel to preparing for the NDA submission, Shire will be assessing the need for gathering additional clinical data in support of the US and potential international regulatory submissions.
“As we prepare for the FDA submission, we will also form an Ophthalmics Business Unit (BU) that will focus on the commercialisation of our ophthalmic pipeline products," said Flemming Ornskov, MD, CEO, Shire. “This BU will be led by Robert Dempsey, who we recently hired from Bausch & Lomb. Bob has more than 20 years of experience in eye care and has been instrumental in the launches of several well- known eye care products. As we build out the BU, Bob will report to Perry Sternberg, Head of the Neuroscience BU, who also has 10 years of ophthalmology experience. In addition, on our clinical development team, we have hired Reza Haque, MD, PhD, as Therapeutic Area Head for Ophthalmology, also from Bausch & Lomb. Reza will be responsible for overseeing the lifitegrast and the Phase II retinopathy of prematurity (ROP) clinical development programmes, and any future programmes in ophthalmics. Reza brings to Shire more than 20 years of experience in ophthalmics.
“Shire is focused on driving and delivering innovation for the betterment of patients. We’re fortunate to have Lifitegrast and our compound for ROP as two potential innovative ophthalmology treatments, and we have every intention of complementing these compounds with additional pipeline products to address significant unmet patient need in ophthalmics,” Dr Ornskov said.
Lifitegrast is an investigational treatment that has been studied in a large clinical development programmeof more than 1800 patients. The compound, a small-molecule integrin antagonist, was designed to treat dry eye disease, and is a preservative-free topical eye solution. Lifitegrast is believed to work by reducing inflammation through inhibition of lymphocyte function-associated antigen 1 (LFA-1) and preventing its binding to intercellular adhesion molecule-1 (ICAM-1) that influences T-cell activation and cytokine (protein) release. The interaction between these two proteins plays a key role in the chronic inflammation associated with dry eye. T-cells are important components of the immune system that help control the body's response to a foreign or harmful substance or stimuli.
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance