Shire to Re-File Its Dry Eye Treatment Lifitegrast with FDA

Shire to Re-File Its Dry Eye Treatment Lifitegrast with FDA

Shares of Shire rose up to 4950p before they closed 318p higher at 4927 after hyperactive buyers heard that the drugmaker is all set to re-file its dry eye treatment Lifitegrast with the Food and Drug Administration (FDA).

As per a report, the drug successfully met both the primary and secondary targets. It also helped to reduce the symptoms in over 84 days and benefits of it were visible within two weeks. In addition, OPUS-3 also met the secondary endpoints of symptom improvement from baseline to days 14 and 42.

Shire’s chief executive Flemming Ornskov said, “We will now re-submit the drug, which could have sales of at least $1billion by 2020 in the first quarter of 2016 and if approved could be launched later in 2016”.

Broker UBS expects that the US launch of the Lifitegrast could be possible in the third quarter of 2016. Analyst David Evans said the data point was a key catalyst for Shire in this year and it will also help the investment case of the company on track.

Followers of Shire also hope that the positive results on Lifitegrast also help Shire’s attempt to buy Baxalta, the US bleeding disorders and immune deficiencies specialist.

Shire is planning to use the data as part of the resubmission of the New Drug Application (NDA) for Lifitegrast for the treatment of signs and symptoms for dry eye disease in the first quarter of 2016.

Philip J. Vickers, Ph.D., Head of Research & Development, Shire, said they strongly hope that data from OPUS-3 will satisfy the FDA’s request for an additional clinical study.

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