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Shire resubmits NDA for lifitegrast in response to FDA request for data
Shire has resubmitted its new drug application to the FDA for lifitegrast, an investigational treatment for dry eye disease, the company announced in a press release.
Shire resubmitted the application in response to a complete response letter in which the FDA requested an additional study. In the resubmission, Shire included data from OPUS-3, a phase 3 safety and efficacy trial. The primary endpoint of OPUS-3 was patient-reported improvement in dry eye symptoms.
The resubmission package also included information on product quality and data from one phase 2 study; OPUS-1 and OPUS-2, two other phase 3 safety and efficacy studies; and the SONATA study, a phase 3 safety study.
The FDA has 30 days after resubmission of an NDA to acknowledge its receipt and determine if it is a complete response. Upon acceptance, the FDA will provide Shire with a PDUFA date within 6 months of the NDA’s resubmission, the release said.