FDA demands product quality information in CRL for Shire's dry eye candidate

By Dan Stanton contact

- Last updated on GMT

FDA demands product quality info in CRL for Shire's dry eye NDA

Related tags: Food and drug administration, Eye

Problems with manufacturing have left Shire with a Complete Response Letter for its dry eye disease small-molecule integrin inhibitor lifitegrast.

Shire’s candidate for dry eye disease in adults, lifitegrast, was granted a Priority Review designation by the US Food and Drug Administration (FDA) in April​, but last week the pharma firm received a complete response letter (CRL) from the Agency requesting more information related to product quality.

Gwen Fisher, a spokesperson from Shire, told in-Pharmatechnologist.com concern stems from the CMC [Chemistry, Manufacturing, and Controls] review of the NDA [which] includes quality attributes in the manufacturing process to ensure product quality.”

She added the firm is: “Confident that we can address this request in our response to the CRL planned for the first quarter of 2016,” ​but when pushed would not go into further details.

In the US, lifitegrast is manufactured by an undisclosed third-party manufacturer.

OPUS-3 Study

Shire was also requested in the CRL to provide an additional clinical study, and the firm hopes to satisfy the FDA’s demands through its OPUS-3 Phase III study which has just been completed.

“If the study is positive, we plan to refile our liftegrast submission in the first quarter of 2016, and will remain on track for the planned lifitegrast launch next year,”​ CEO Flemming Ornskov said in a statement.

“We are committed to working with FDA to expeditiously provide the evidence required to deliver a new prescription treatment option for the 29 million adults in the US living with the symptoms of this chronic and progressive disease.”

Lifitegrast is a small-molecule integrin inhibitor which is intended to stop the over-expression of ICAM-1 (intercellular adhesion molecule-1) in corneal and conjunctival tissues in dry eye disease.

The candidate binds to the integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface protein found on leukocytes, and blocks the interaction with ICAM-1, resulting in T-cell activation and migration to target tissues.

Related topics: Processing, Regulations, QA/QC

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