Seroquel XR Might Get Second Line For Depression, Anxiety Despite Safety Worry
Executive Summary
A second-line indication for AstraZeneca's Seroquel XR (quetiapine) in major depressive disorder and generalized anxiety disorder remains possible following a unanimous FDA advisory committee vote that the drug is not "acceptably safe" for the monotherapy claims in MDD and GAD that AstraZeneca had been seeking
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Regulatory Updates, In Brief
FDA won't review Merck Serono's oral cladribine NDA: FDA refused to file the NDA for Merck Serono's oral multiple sclerosis drug cladribine, the firm announced Nov. 30. The application was filed in September by the company's U.S. subsidiary EMD Serono (1"The Pink Sheet" DAILY, Sept. 30, 2009). FDA granted the cladribine NDA fast track status based on the need for an oral therapy in the subset of MS patients with relapsing disease. Though Merck Serono was first to submit an NDA for an oral therapy for relapsing MS, it has not been the odds-on favorite for first approval (2IN VIVO, November 2009). At Windhover's FDA/CMS Summit Dec. 3, FDA Office of New Drugs Director John Jenkins spoke generally of the agency's refuse-to-file actions, noting that if industry wants FDA to meet PDUFA review dates, complete applications must be submitted (3The IN VIVO Blog, Dec. 3, 2009)
Regulatory Updates, In Brief
FDA won't review Merck Serono's oral cladribine NDA: FDA refused to file the NDA for Merck Serono's oral multiple sclerosis drug cladribine, the firm announced Nov. 30. The application was filed in September by the company's U.S. subsidiary EMD Serono (1"The Pink Sheet" DAILY, Sept. 30, 2009). FDA granted the cladribine NDA fast track status based on the need for an oral therapy in the subset of MS patients with relapsing disease. Though Merck Serono was first to submit an NDA for an oral therapy for relapsing MS, it has not been the odds-on favorite for first approval (2IN VIVO, November 2009). At Windhover's FDA/CMS Summit Dec. 3, FDA Office of New Drugs Director John Jenkins spoke generally of the agency's refuse-to-file actions, noting that if industry wants FDA to meet PDUFA review dates, complete applications must be submitted (3The IN VIVO Blog, Dec. 3, 2009)
AstraZeneca Will Collect Longer-Term Safety Data For Seroquel XR
AstraZeneca is committed to new studies and could modify ongoing observational studies to collect data on the long-term safety issues that troubled an FDA advisory panel during its consideration of Seroquel XR (quetiapine) for treating major depressive disorder and generalized anxiety disorder