Shire’s dry eye treatment gets a no – for now
pharmafile | October 19, 2015 | News story | Sales and Marketing | Complete Response Letter, FDA, Flemming Ornskov, Shire, dry eye disease, lifitegrast
Shire has seen an application for its dry eye treatment lifitegrast rejected by the US regulator.
The FDA says it needs more information from Shire before making a decision about lifitegrast, a treatment on which much of Shire’s pipeline hopes rest. The drug, if approved, would be the first available to with an indication to treat both signs and symptoms of the disease.
The news is a blow for Shire, which is to trying to buy Baxalta to forge the leading global specialist in rare diseases. It has already seen the value of its all-share offer, initially worth $30 billion, fall by more than a fifth.
The FDA requested an additional clinical study as part of a complete response letter (CRL) to the company’s new drug application for lifitegrast for the signs and symptoms of dry eye disease in adults. The FDA also requested more information related to product quality, which Shire says it ‘is confident it can address’.
Shire has recently completed a Phase III study of lifitegrast, OPUS-3, that, if positive, will be the basis of its response to the CRL, says chief executive Flemming Ornskov.
“We were disappointed, but will soon have data from the Phase III study, OPUS 3, which has now been completed and top-line data are expected before the end of the year. If the study is positive, we plan to refile our liftegrast submission in the first quarter of 2016, and will remain on track for the planned lifitegrast launch next year.
“We are committed to working with FDA to expeditiously 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.”
Lilian Anekwe
For more on the market for dry eye disease treatments, read Black Swan Analysis’ in-depth Epiomic™ Epidemiology Series Forecast Report on Dry Eye Syndrome in 7 Major Markets. Click here to read the summary and purchase the report.
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