Shire's ($SHPG) once-rejected treatment for dry eye disease has another date with the FDA, supported by new data the company believes will get the drug on the market and eventually help bring in more than $1 billion in annual revenue.
The treatment, lifitegrast, is a small-molecule drug meant to interrupt the immune process that leads to dry eye disease. The FDA rejected Shire's first application in October, unmoved by a Phase III trial in which the treatment succeeded on only one of its two primary endpoints. Shire submitted results from another late-stage study shortly thereafter, finding that lifitegrast notched a statistically significant reduction in patient-reported eye dryness compared with placebo after 12 weeks.
The Irish-headquartered drugmaker has since reapplied for approval, and the agency today promised to hand down another verdict on lifitegrast by July 22. Shire has tabbed the drug as a blockbuster in the making, citing it as a keystone of the company's recently formed ophthalmics division.
"We believe that this resubmission package, which includes our positive OPUS-3 data, as well as information about product quality, will address the requests from the FDA," Shire R&D chief Philip Vickers said in a statement. "Ophthalmics is a key focus area for Shire, and we're pleased to see our lead candidate continue to advance."
Shire is awaiting the close of its $32 billion merger with Baxalta ($BLXT), a deal CEO Flemming Ornskov has said will help the company grow its revenue to $20 billion by 2020.
- read the statement