Regulatory Round-Up: Drug Review Profiles From 2012

Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile. If you do not have access, contact customer care at 1-800-332-2181 for a free copy of any of these articles.

AstraZeneca’s Brilinta	(Also see "Multiple Aspirin Dose Analyses Reassured FDA On Brilinta’s U.S. Efficacy" - Pink Sheet, 1 Jan, 2012.) (Also see "Shades Of Prasugrel: Brilinta Review Felt The Effects Of Effient’s Experience" - Pink Sheet, 1 Jan, 2012.) (Also see "Brilinta Review Sparks War Of Words Between FDA Cardio-Renal Division’s Marciniak, Stockbridge" - Pink Sheet, 1 Jan, 2012.)
Shire’s Firazyr	(Also see "Persistence, Secondary Endpoints Helped Shire Get FDA Nod For Firazyr Novel PRO" - Pink Sheet, 1 Feb, 2012.) (Also see "Different Endpoints Drive HAE Drugs On Road To Approval" - Pink Sheet, 1 Feb, 2012.) (Also see "Firazyr Efficacy Findings Were Muddied By Choice Of Comparator" - Pink Sheet, 1 Feb, 2012.) (Also see "FDA Relies On Experience To Judge Firazyr Self-Administration" - Pink Sheet, 1 Feb, 2012.)
Pfizer’s Xalkori (crizotinib)	(Also see "Synchronized Regulation: Tandem Approvals Of Xalkori, Diagnostic Required Considerable Coordination" - Pink Sheet, 1 Mar, 2012.) (Also see "Untargeting Xalkori? Hints Of Efficacy In ALK-Negative Patients Must Be Addressed, FDA Says" - Pink Sheet, 1 Apr, 2012.)
J&J/Bayer’s Xarelto (rivaroxaban)	(Also see "Xarelto Tested FDA’s Comparative Efficacy Powers, But Conservative View Prevailed" - Pink Sheet, 1 May, 2012.) (Also see "FDAer Eyes Improvements In Anticoagulant Trial Design" - Pink Sheet, 1 May, 2012.) (Also see "The Xarelto Trials That Might Have Been" - Pink Sheet, 1 May, 2012.)
Vertex’s Kalydeco (ivacaftor)	(Also see "Kalydeco Passed FDA’s Approval Test With The Help Of A Failed Study" - Pink Sheet, 19 Jun, 2012.) (Also see "Secondary Endpoints Backed Kalydeco’s Efficacy, Despite Lack Of Correlation With Pulmonary Function" - Pink Sheet, 19 Jun, 2012.)
Amylin’s Bydureon (exenatide extended-release)	(Also see "Bydureon Approval Provides Lesson In Clinical Data Requirements For Biosimilars" - Pink Sheet, 1 Jul, 2012.) (Also see "Bydureon Review Documents Paint An Unflattering Portrait Of Amylin" - Pink Sheet, 1 Jul, 2012.)
Corcept Therapeutics’ Korlym (mifepristone)	(Also see "FDA’s Decision To Back Off Korlym REMS Shows Context Is King" - Pink Sheet, 1 Sep, 2012.) (Also see "Korlym’s Mechanism Of Action Complicated Cushing’s Trial Design" - Pink Sheet, 1 Sep, 2012.) (Also see "Will Novartis’ Pasireotide Find A Simpler Road To Approval In Cushing’s?" - Pink Sheet, 1 Sep, 2012.)
Arena’s Belviq (lorcaserin)	(Also see "Arena Finds Antidote For Belviq’s Theoretical Risk Of Valvulopathy In Mechanistic Studies" - Pink Sheet, 1 Oct, 2012.) (Also see "FDA Clears Belviq With Post Hoc Finding Of Less Than Double Placebo CV Risk" - Pink Sheet, 1 Oct, 2012.) (Also see "Judging Obesity Drugs: Can Patient-Focused Statistics Bring Simplicity, Clarity?" - Pink Sheet, 1 Oct, 2012.)
Roche/Genentech’s Erivedge (vismodegib)	(Also see "Erivedge Efficacy Overcomes Limitations Of Single-Arm Study" - Pink Sheet, 1 Nov, 2012.) (Also see "To REMS Or Not To REMS? Erivedge Shows Division At FDA Over Oncology Risk Management" - Pink Sheet, 1 Nov, 2012.)
Medivation/Astellas’ Xtandi (enzalutamide)	(Also see "Accelerated Evolution Of Prostate Cancer Therapy Shaped Xtandi Review" - Pink Sheet, 18 Dec, 2012.) (Also see "Momentum In Prostate Cancer Therapy Moves Up To First-Line CRPC" - Pink Sheet, 18 Dec, 2012.)