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FDA to decide on Shire blockbuster hopeful

pharmafile | February 8, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Shire, dry eye disease, lifitegrast 

The FDA has accepted Shire’s new drug application (NDA) for its dry eye disease drug lifitegrast, putting the treatment on course for a final approval decision in July.

The Irish company resubmitted the application for a second time in late January, having received a complete response letter for its prior submission, initially sent to the regulator in February 2015. In the letter, the FDA requested an additional clinical study and more information related to product quality, creating a delay in getting the potential blockbuster drug to market that was considered a blow to Shire at the time.

Shire quickly responded with the requested data, and this time, the FDA determined that the submission is a complete response, and has assigned a six-month review period for the NDA and a Prescription Drug User Fee Act (PDUFA) goal date of July 22, 2016.

The new drug application for lifitegrast now includes data from five clinical trials, including one Phase II study, three Phase III safety and efficacy studies (OPUS-1, OPUS-2 and OPUS-3) and one long-term (one year) Phase III safety study (SONATA). Shire claims this to be the largest clinical trial program for an investigational-stage compound in dry eye disease, with over 2,500 patients.

Philip Vickers, head of Research & Development at Shire, comments: “The resubmission is an important milestone for Shire and our commitment to providing a new treatment option for the 29 million adults in the US living with the symptoms of dry eye disease. 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.”

Lifitegrast has long been seen as a promising treatment in an area of unmet clinical need. Shire, which recently completed a $32 billion takeover of rare disease specialist Baxalta, sees the drug as an important part of its plan to reach annual sales of $20 billion by 2020.

Joel Levy

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