America’s drug regulator has refused to approve a medicine for dry eye disease made by Shire, dealing a blow to the Irish drug maker’s hopes of generating sales of more than $1 billion.
The Federal Drug Administration said that it would not approve lifitegrast in its present form and requested further information relating to product quality. The drug potentially is one of the most important new treatments in Shire’s drug pipeline.
Chronic dry eye syndrome affects the tear-producing glands and can cause an itching or burning sensation and blurred vision. The ailment affects up 100 million people worldwide and the market for treatments is estimated to be worth more than $2.4 billion, of which lifitegrast could claim almost half, according to analysts.
At present, there is only one approved pharmacologic treatment for dry eye, Restasis, made by Allergan.
The FDA setback comes as Shire is trying to take over Baxalta in an effort to become one of the biggest operators in the rare diseases sector. Since Shire said that it wanted to buy Baxalta, volatility in its share price has meant that the value of its all-share offer — worth £19 billion at first — has fallen heavily. There has been speculation that Shire could set its sights on Radius Health if the Baxalta deal falls through.
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Flemming Ornskov, the chief executive of Shire, admitted that he was “disappointed” with the FDA’s decision on lifitegrast. He said that Shire would persevere with a phase-III trial this year, which could provide data to convince the regulator.
“If the study is positive, we plan to refile our lifitegrast submission in the first quarter of 2016 and will remain on track for the planned lifitegrast launch next year,” Mr Ornskov said. “We are committed to working with the FDA expeditiously to provide the evidence required to deliver a new prescription treatment option for the 29 million adults in the US living with the symptoms of this chronic and progressive disease. This is an area of unmet medical need for which there has been no new FDA-approved treatment in over a decade.”
One of the reasons that dry-eye treatments ran into regulatory approval hurdles in the United States is that the FDA wants medicines to show improvement in both the clinical signs — objective evidence of a disease — and the symptoms, which often can be felt or sensed only by the patient.
Restasis was approved after it showed a statistically significant improvement in the clinical signs of dry eye, even though it did not show significant improvement in the symptoms.
Jefferies said that the FDA’s decision on lifitegrast was likely to be a temporary setback and Shire’s shares rose 115p to £46.26.