USFDA eye drug rebuff adds to Shire's woes in Baxalta pursuit
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The Irish company said the U.S. Food and Drug Administration (FDA) had declined to approve its new eye drug lifitegrast and had requested an additional clinical study.
The news comes just over a week before the FDA was supposed to make a decision on the treatment for dry eye disease, which analysts have penciled in as a potential $1 billion-a-year-plus seller.
Shire said it received a so-called complete response letter from the FDA. Such letters are sent out to let a drug developer know a marketing application will not be approved in its present form.
The setback is likely to hit shares in Irish-based Shire, which have already lost more than a fifth of their value since it announced an all-share offer to buy U.S. rival Baxalta in early August, which was worth $30 billion at the time.
Shire's stock has been hit both by uncertainty over the Baxalta bid and a wider rout in pharmaceutical stocks, triggered by mounting investor concerns about political pressures on U.S. drug prices.
The news comes just over a week before the FDA was supposed to make a decision on the treatment for dry eye disease, which analysts have penciled in as a potential $1 billion-a-year-plus seller.
Shire said it received a so-called complete response letter from the FDA. Such letters are sent out to let a drug developer know a marketing application will not be approved in its present form.
The setback is likely to hit shares in Irish-based Shire, which have already lost more than a fifth of their value since it announced an all-share offer to buy U.S. rival Baxalta in early August, which was worth $30 billion at the time.
Shire's stock has been hit both by uncertainty over the Baxalta bid and a wider rout in pharmaceutical stocks, triggered by mounting investor concerns about political pressures on U.S. drug prices.
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