London-listed pharmaceutical firm Shire said its dry-eye disease drug lifitegrast significantly improved patient symptoms in a new study, supporting a re-submission of the potentially block-busting medicine to United States regulators early next year.
Shares in Shire jumped more than six per cent after it announced the positive results of the study on Tuesday.
The US Food and Drug Administration declined to approve lifitegrast earlier this month, saying it wanted more data from an additional clinical study.
Shire's chief executive Flemming Ornskov said the company would resubmit the drug, which it has said could have sales of at least $1 billion a year by 2020, in the first quarter, and if approved it could be launched later in 2016.
"We have a very attractive package to refile with the FDA," he said.
The randomised study had delivered "pretty amazing data" that showed the product worked within 14 days, he said, and if approved, it would make available a new class of drug to treat a condition that affected about 29 million Americans.
A submission in Europe would follow, he said, and the company was also looking at the Canadian and Japanese markets.
Analysts at Jefferies said the new study - the fifth in total for the medicine - would boost the likelihood of approval, a development which justified around a five per cent uptick in the stock price.
They said the FDA had indicated that the only other prescription drug on the market for the condition - Restasis - had only marginal efficacy, setting a relatively low bar for approval.
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