Shire hit with another setback as FDA rejects top pipeline drug Print E-mail
By John Carroll - FierceBiotech   
Friday, 23 October 2015 09:59

Shire CEO Flemming Ornskov has yet another setback to grapple with as his company winds toward the end of a strange year. The FDA has rejected the company's application for the dry-eye drug lifitegrast, a key drug that the biotech has billed as a blockbuster earner, despite its mixed record in the clinic.

The FDA is demanding another clinical trial along with more quality info on the drug, according to Shire ($SHPG), which put out the news late on Friday. And the biotech says it's eager to respond, preparing to add new data from a recently completed Phase III trial.

Analysts started shaking their heads about lifitegrast's prospects at the FDA back in late 2013, when the eye drug missed one of two primary endpoints in a study. The drug failed to reduce corneal staining, a key objective indication of efficacy, though it did clear a hurdle for patient-reported symptoms. Bagging this drug was one of Ornskov's first moves as the newly named chief, when he bought SARcodefor $160 million upfront plus milestones.




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