- Shire has received a new PDUFA date for its dry eye drug lifitegrast after the FDA accepted its resubmitted new drug application (NDA). The FDA assigned the drug a six-month review period, setting an action date of July 22, 2016.
- The FDA in October 2015 had decided against approving lifitegrast because it had failed to hit a major trial endpoint. After receiving the FDA's complete response letter, Shire resubmitted a new drug application (NDA) including data from five clinical trials.
- With the five clinical trials and 2,500 plus patients, Shire claims the lifitegrast trial program is the largest for an investigational-stage compound in dry eye disease.
Shire's new phase 3 data includes positive outcomes from a 12-week, placebo-controlled trial where patients had statistically significant improvements in their dry eye disease symptoms. The resubmitted NDA includes this OPUS-3 trial data, along with product quality information
Lifitegrast has a unique mode of action. It is an intercellular adhesion molecule (ICAM) inhibitor that modifies the immune functions that lead to dry eye.
Shire has pegged lifitegrast as a likely blockbuster. Currently, Allergan's Restasis is the only approved treatment for dry eye disease, leaving the market ripe for a new entrant.
In many ways, Shire is in a holding pattern as it waits for the $32 billion Baxalta deal to close. However, it stands by its 2020 target of $20 billion in revenue—more than triple Shire's $6 billion in 2014 revenue. An approval of lifitegrast this summer would boost its ability to close the gap.