Dive Brief:
- The Food and Drug Administration approved Shire's ophthalmic drug Xiidra (lifitegrast) as the first treatment of both the signs and symptoms of dry eye disease, the company announced Monday.
- Shire has repeatedly labeled the drug a likely blockbuster, as it treats a disease that afflicts more than 14 million people in the U.S.
- The drug was originally expected for approval in October 2015, but the FDA rejected the drug at the time for lack of clinical data. The company resubmitted the drug for approval January 2016 following largely positive outcomes from another phase 3 study (OPUS-3).
Dive Insight:
"Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, approved by the FDA for dry eye disease," according to the FDA.
And Shire's public records reveal the company seeks to take full advantage of its "first" label while treating dry eye disease. Shire's Q1 presentation on Xiidra (lifitegrast) notes the company expects to tap into a largely untreated market: 14 million people are diagnosed with the chronic condition, but only a fraction of these are undergoing treatment.
That's because prior to the approval of Xiidra, Allergan's Restasis was one of the only options to treat dry eye disease. With this market advantage, Restasis brought in roughly $1 billion in global sales in 2015.
But Shire hopes Xiidra's clinical attributes will allow the drug to successfully compete with Restasis and eventually reach blockbuster status as well. "The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the U.S. specifically to treat both the signs and symptoms of the condition," said Flemming Ornskov, Shire's CEO, in a celebratory statement.
Regardless of the competitive outlook, the approval marks a big win during a big year for Shire.
The company has announced it aims reach $20 billion in annual sales by 2020. Although Shire reported only $6.1 billion in sales during 2015, the past year saw the company aggressively expand its portfolio. Most notably, Shire effectively doubled its annual projected sales with this year's $32 billion acquisition of Baxalta, which reported about $6 billion in sales during 2015.
Add to the mix a few other acquisitions and its potential blockbuster entering the market this year, and Shire is well on its way to meeting its ambitious goal.