FDA Declines to Approve Shire’s Lifitegrast Treatment for Dry Eye

The FDA dealt Shire’s promising dry eye treatment lifitegrast a setback, requesting an additional clinical study and more product quality information just days before the drug’s anticipated approval date.

The no-go decision means Allergan’s Restasis (ciclosporin) will remain the only approved drug in the U.S. market to treat dry eye, which affects more than 29 million adults. Lifitegrast is the first contender to come along in over a decade.

Shire plans to submit data from a recently completed Phase 3 study of lifitegrast as the basis of its Complete Response Letter response. The results are expected before the end of the year, putting the firm on target for resubmission of its NDA in the first quarter of 2016 and product launch sometime next year, CEO Flemming Ornskov says.

The drugmaker will also provide the FDA with an assessment of the manufacturing process for lifitegrast. While declining to offer specifics, Shire spokeswoman Gwen Fisher saidthat the firm is “confident we can address this request” in its response to the CRL.

The drug was granted a priority review in April, setting the FDA PDUFA clock to Oct. 25.

Shire recently boosted its ophthalmics portfolio with this summer’s acquisition of Foresight Biotherapeutics for $300 million. Shire’s recent purchases in the eye care arena include SARcode Bioscience, Premacure AB and BIKAM Pharmaceuticals. — Kellen Owings