Shire has announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for 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) received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act (PDUFA) goal date of July 22, 2016.
"The resubmission is an important milestone for Shire and our commitment to providing a new treatment option for the 29 million adults in the U.S. living with the symptoms of dry eye disease," said Philip J. Vickers, Ph.D., Head of Research & Development, Shire. "We believe that this resubmission package, which includes our positive OPUS-3 data, as well as information about product quality, will address the requests from the FDA. Ophthalmics is a key focus area for Shire, and we're pleased to see our lead candidate continue to advance."
The new drug application for lifitegrast now includes data from five clinical trials, including one Phase 2 study, three Phase 3 safety and efficacy studies (OPUS-1, OPUS-2 and OPUS-3) and one long-term (one year) Phase 3 safety study (SONATA). This is the largest clinical trial program for an investigational-stage compound in dry eye disease with over 2,500 patients.
Shire originally submitted the NDA for lifitegrast to the FDA in February 2015. In April 2015, the FDA granted Priority Review designation to lifitegrast, which accelerated the review target to eight months instead of the standard 12 months.