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Shire Says Lifitegrast Meets Goals With Potential For 2016 Launch

27th Oct 2015 11:09

LONDON (Alliance News) - Irish pharmaceuticals group Shire PLC on Tuesday said its Lifitegrast treatment for dry eye disease has met the primary and secondary endpoints in a phase-3 study of the drug.

FTSE 100-listed Shire said the study showed Lifitegrast significantly reduced patient-reported symptoms for dry eye disease and supports the re-subsmission of the treatment to the US Food and Drug Administration in the first quarter.

Plans are therefore on track for a potential 2016 launch of the treatment, Shire said.

Shire had faced a setback earlier this month when the US regulator requested an additional clinical study be undertaken as part of its complete response letter to the new drug application made for lifitegrast.

Shire shares were up 4.3% to 4,806.00 pence on the news, the best performer in the FTSE 100.

By Sam Unsted; [email protected]; @SamUAtAlliance

Copyright 2015 Alliance News Limited. All Rights Reserved.


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