As­traZeneca's COPD triple ther­a­py slammed by CRL — falling fur­ther be­hind GSK

Days af­ter tout­ing key ad­vances for its on­col­o­gy strat­e­gy, As­traZeneca is be­ing slapped by a reg­u­la­tor set­back in the res­pi­ra­to­ry space.

The FDA has re­fused to ap­prove PT010, a much-tout­ed triple-drug com­bi­na­tion for chron­ic ob­struc­tive pul­monary dis­ease that it had hoped would chal­lenge Glax­o­SmithK­line. The com­plete re­sponse let­ter fol­lowed an OK in Japan sev­er­al months ago, push­ing the drug on­to the mar­ket as Breztri Aeros­phere.

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