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 The green light from the European Medicines Agency (EMA) for
olaparib, or Lynparza, is welcome news since the product hit a road
bump in June when a U.S. panel voted against its accelerated
approval.
AstraZeneca has flagged the medicine as a potential $2
billion-a-year seller.
Olaparib blocks an enzyme involved in cell repair and is designed
for patients with certain hereditary gene mutations. It also has
promise in treating breast and gastric cancers, opening up a
substantial market opportunity.
The EMA said its committee of experts on new drugs also recommended
approval of Pfizer's Duavive for oestrogen deficiency, Baxter
International's Rixubis for hemophilia and Clinuvel's Scenesse for
phototoxicity.
Recommendations for marketing approval by the European Medicine
Agency's Committee for Medicinal Products for Human Use (CHMP) are
normally endorsed by the European Commission within a couple of
months.
(Reporting by Ben Hirschler; Editing by Tom Bergin)
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