5th Feb 2016 08:53
LONDON (Alliance News) - Shire PLC on Thursday said the US Food and Drug Administration has acknowledged receipt of the resubmission of its 'new drug' application for lifitegrast, which is designed to treat dry eye disease in adults.
The FTSE 100 pharmaceutical company resubmitted the application in response to a notice from the FDA in October 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 six-month review period for the new drug application and a Prescription Drug User Fee Act goal date of July 22.
"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," said Philip Vickers, Shire's head of research & development, said.
"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," Vickers added.
Shares in Shire were up 0.7% at 3,758.00 pence on Friday morning.
By Samuel Agini; [email protected]; @samuelagini
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