AstraZeneca Ovarian-Cancer Drug Wins EU Agency’s BackingPhil Serafino
AstraZeneca Plc won backing from a European Union regulator for an ovarian-cancer drug, one of the experimental medicines the company cited as a reason for fending off Pfizer Inc.’s $117 billion takeover offer this year.
The treatment, olaparib, should receive a marketing authorization for use in patients with a mutation in one of two genes called BRCA, the European Medicines Agency’s Committee for Medicinal Products for Human Use said in a statement today. The European Commission usually follows the committee’s recommendation. The drug will be marketed under the name Lynparza.
“We are delighted that the CHMP has recommended Lynparza,” Briggs Morrison, chief medical officer at AstraZeneca, said in a separate statement. “We are committed to investigating the full potential of olaparib and have a number of studies under way in multiple tumor types including breast and gastric cancer.”
Lynparza is the first in a new class of drugs that block the actions of proteins called PARP. AstraZeneca said Pfizer’s hostile takeover offer undervalued the company’s pipeline of experimental drugs, including olaparib.
Advisers to the U.S. Food and Drug Administration voted 11-2 in June that the company should complete a study to confirm the drug’s benefit, before the agency considers approving it. London-based AstraZeneca scrapped plans for the drug in 2011, only to revive them after deciding to reanalyze data on patients with a mutation of the BRCA genes.
The FDA is expected to decide whether to approve olaparib by Jan. 3.
AstraZeneca fell 0.2 percent to close at 4,327.5 pence in London.