Shire submits dry-eye drug for marketing approval
pharmafile | August 15, 2017 | News story | Manufacturing and Production, Sales and Marketing | Shire, biotech, drugs, pharma, pharmaceutical
Shire has announced that it has submitted its dry-eye drug, lifitegrast, for European marketing approval. The filing comes after it gained approval in the US for the treatment of dry eye disease over a year ago.
The drug, known by its brand name Xiidra in the US, had been knocked back by the FDA after the agency required that the company had to provide more clinical data on the drug. It means that Shire is able to apply for European marketing approval with a substantial amount of clinical information to back it up.
In particular, the company had conducted five separate clinical trials for the treatment that included more than 2,500 patients.
Since it was approved in the US, Xiidra has managed to garner $150 million in revenue. It arrived in the market as the second treatment to address dry eyes, with Regeneron’s Restasis having been on the market to treat chronic dry eye disease for the last decade.
Shire’s product, however, has managed to swipe 22% of the dry market since its launch. Analysts expect it to reach blockbuster levels by 2022, should approval in Europe go as planned.
Part of the reason for the product’s success in the US was noted by Shire’s CEO, Flemming Ornskov, as a direct result of its ‘awareness campaign’ to encourage more people to enquire about dry eye treatments from their physicians.
“This submission is another important milestone for lifitegrast and the millions of patients living with dry eye disease, which can impact a person’s vision-related quality of life, affecting daily activities such as reading and using computers,” said Howard Mayer, Head of Clinical Development, R&D at Shire. “Shire is committed to continued innovation in ophthalmics, where there are opportunities to address unmet need and improve the lives of patients.”
The move into the ophthalmology market represents a shift for the company that had previously focused on rare diseases. However, it is doubling down on its efforts in the area with a follow-up drug for dry eye conditions also in the pipeline, along with other treatments for infectious conjunctivitis and glaucoma.
Ben Hargreaves
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