16th May 2014 15:53
LONDON (Alliance News) - Shire PLC Friday said that it plans to submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults.
The pharmaceutical company said that the new submission should take place in the first quarter of 2015, after it completes certain chemistry and manufacturing work. The news follows a meeting the company had with the US Food and Drug Administration Thursday.
Shire said that it will also be assessing the need to gather additional clinical data in support of the US application, and potential international regulatory submissions necessary for the treatment.
Lifitegrast is an investigation treatment designed for dry eye disease in adults that has been studied in a large clinical development program of more than 1,800 patients.
"As we prepare for the FDA submission, we will also form an Ophthalmics Business Unit that will focus on the commercialization of our ophthalmic pipeline products," Shire Chief Executive Flemming Ornskov said in a statement.
Shire shares closed down 0.6% at 3,249.399 on Friday.
By Tom McIvor; [email protected]; @TomMcIvor1
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