Bayer gets FDA priority
review for blood cancer drug
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[May 17, 2017] FRANKFURT,
Germany (Reuters) - German drugmaker Bayer won the U.S. Food and Drug
Administration's priority review status for an experimental drug for a
difficult to treat type of blood cancer, bolstering its development
pipeline.
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Based on results of a Phase II study, the FDA plans to review
Bayer's copanlisib within six months instead of the usual 10 for use
against follicular lymphoma which has returned or persisted despite
at least two prior therapies, the company said in a statement on
Wednesday.
Bayer, which is taking over U.S. seeds group Monsanto, is trying to
follow up in its drug development efforts on the recent success of
blood thinner Xarelto and anti-blindness treatment Eylea.
"Copanlisib may have a greater success and potential than we
initially anticipated," Bryan Garnier analysts said, adding they
would revise their current peak sales estimate of 600 million euros
($666 million).
Bayer has said it was targeting peak annual sales of more than 500
million euros for the compound.
The Phase II trials has previously shown that copanlisib lead to the
cancer receding in close to 60 percent of participants.
($1 = 0.9014 euros)
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(Reporting by Ludwig Burger, editing by Louise Heavens)
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