- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Shire resubmits NDA for lifitegrast to the FDA
25 January 2016 • Author: Victoria White
Shire has resubmitted the New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational candidate, lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults.
Shire resubmitted the NDA in response to the complete response letter (CRL) the company received from the FDA in October last year.
Addressing the FDA request for an additional study, Shire included in its NDA resubmission package data from OPUS-3, a Phase 3 efficacy and safety trial with a primary endpoint of patient-reported symptom improvement. The resubmission package also included information requested by the FDA regarding product quality.
Commenting on the resubmission, Philip J. Vickers, Ph.D., Head of Research & Development, Shire, said, “The NDA for lifitegrast now includes data from five randomised controlled clinical trials, with more than 2,500 patients, making it the largest data set for an investigational stage compound in dry eye disease to date. Because we believe that, if approved, lifitegrast has the potential to help the millions of U.S. adults living with symptoms of dry eye disease, we worked diligently to submit our response to the CRL as quickly as possible. This is an important milestone for Shire and underscores our commitment to providing innovative new treatment options in areas of unmet medical need.”
The new drug application for lifitegrast now includes data from one Phase 2 study, three Phase 3 efficacy and safety studies (OPUS-1, OPUS-2 and OPUS-3), and one long-term (one-year) Phase 3 safety study (SONATA).
The FDA has 30 days after resubmission of an NDA to acknowledge receipt and determine if the submission is a complete response. Upon acceptance, the FDA will provide Shire with a PDUFA date anticipated to be within six months of the date of submission.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics