Shire tries again with lifitegrast dry eye FDA application
pharmafile | January 25, 2016 | News story | Manufacturing and Production, Sales and Marketing | FDA, Shire, dry eye disease, lifitegrast
Shire has resubmitted its New Drug Application (NDA) to the US FDA for its rejected dry eye syndrome drug lifitegrast.
After Shire’s first application the FDA issue a complete response letter in October 2015, requesting additional study data to prove efficacy.
To address the FDA’s request for an additional study, Shire included in its NDA resubmission data from the Phase III OPUS-3 trial, as well as additional information requested by the Administration regarding product quality.
Philip Vickers, head of research and development at Shire, is confident the robust data of the resubmitted application would see lifitegrast approved at the second time of asking.
“The NDA for lifitegrast now includes data from five randomized 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,” he says. “Because we believe that, if approved, lifitegrast has the potential to help the millions of US 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 II study, three Phase III 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. If it accepts the resubmission, the FDA will provide Shire with a Prescription Drug User Fee Act (PDUFA) date anticipated to be within six months of the date of submission. This means the Irish company – which this month completed a $32 billion takeover of fellow rare disease specialist Baxalta – could expect a final decision by June.
The global market for dry eye disease treatments is a growing one, estimated to double to some $4.6 billion by 2024. Analyst GlobalData predicts lifitegrast will become a blockbuster drug with sales in excess of $1 billion per year if given the green light, following in the footsteps of Allergan’s Restasis (cyclosporine emulsion).
Joel Levy
Read an analysis of the market for dry eye disease, by industry experts Black Swan Analysis. To purchase the report go to www.pharmafile.com/market-reports.
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