Shire resubmits NDA for Lifitegrast to US FDA

Ireland-headquartered Shire (LSE: SHP) said today it has resubmitted the New Drug Application to the US Food and Drug Administration for its investigational candidate, lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults.

Shire resubmitted the NDA in response to the Complete Response Letter (CRL) the company received from the FDA last fall (The Pharma Letter October 17, 2015).

Assuming approval, it is estimated the drug could generate $1.5 billion in sales for the company, although analysts at UBS have suggested that peak sales of $2 billion are possible, noting that “consensus (risk-adjusted) sales of $630 million in 2020 seem substantially too low.”