FDA requests additional data in complete response letter for SHP 606 (lifitegrast) in dry eye disease- Shire
The FDA has requested an additional clinical study as part of a complete response letter (CRL) to the new drug application for SHP 606 (lifitegrast), from Shire, for the signs and symptoms of dry eye disease in adults. Shire has recently completed a Phase III study of lifitegrast, OPUS-3, that is expected to be the basis of Shire's response to the CRL.
The FDA also requested more information related to product quality, which Shire will address in the CRL response. Topline results of OPUS-3 are expected before year-end, and, and if positive, the company plans to submit these data as part of a resubmission to the FDA during the first quarter of 2016.The new drug application for lifitegrast included data from four randomised, controlled clinical trials with more than 1,800 patients. These include one Phase II study, two Phase III efficacy and safety studies (OPUS-1 and OPUS-2), and one long-term Phase III safety study (SONATA).
Comment: Lifitegrast will be a competitor to long-established Restasis (ciclosporin 0.05%) from Allergan which claims patent protection until 2024 but is under generic challenge.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins