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FDA requests additional clinical study in complete response letter to lifitegrast NDA
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The FDA requested an additional clinical study in a complete response letter regarding the new drug application for lifitegrast for the signs and symptoms of dry eye disease in adults, according to a press release from Shire.
“We will work quickly to address the FDA’s requests related to lifitegrast, as we are committed to delivering a new prescription treatment option for the 29 million adults in the U.S. living with symptoms of this chronic and progressive disease,” Philip J. Vickers, PhD, head of research and development of Shire, said in the release.
Shire plans to respond to the letter with topline results from OPUS-3, the recently completed phase 3 study of lifitegrast.
The FDA also requested more information regarding product quality, which the company will address in the response, the release said.
“OPUS-3 has now been completed, and topline data are expected before the end of the year. If the study is positive, we plan to refile our lifitegrast submission in the first quarter of 2016 and will remain on track for the planned lifitegrast launch next year,” Flemming Ornskov, MD, CEO of Shire, said in a separate press release.
Flemming Ornskov
The NDA for lifitegrast included data from four clinical trials with more than 1,800 patients: a phase 2 study, two phase 3 efficacy and safety studies (OPUS-1 and OPUS-2) and one long-term phase 3 safety study (SONATA), the release said. OPUS-3 involved 711 patients and evaluated the efficacy and safety of lifitegrast over 12 weeks. The primary endpoint is symptom improvement reported by patients using the Eye Dryness Score scale.