Sanofi-Aventis Gets Priority Review For Second-Generation Atrial Fib Drug
This article was originally published in The Pink Sheet Daily
Executive Summary
Approval could come in early 2009 for Cordarone successor Multaq.
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Two years after FDA deemed Sanofi-Aventis' Multaq (dronedarone) "not approvable" citing safety concerns, the agency has granted a priority review for Sanofi's resubmitted NDA. A six-month priority review could position Multaq - a second-generation atrial fibrillation candidate - for approval in early 2009. Sanofi also has filed for marketing authorization in Europe. The U.S. action date for the multi-channel blocker is Jan. 31, 2009. Sanofi highlighted Multaq during its second-quarter earnings call Aug. 8, pointing to a potential target market of 6 million users, roughly two-thirds of whom would be first-time atrial fibrillation/atrial flutter patients. The remaining one-third are "permanent patients" whose antiarrhythmic heartbeats continue despite other treatment, Exec VP-Pharmaceutical Operations Hanspeter Spek explained during the call (1 (Also see "Sanofi-Aventis Pares Pipeline, Ditches Antidepressant Amibegron" - Pink Sheet, 11 Aug, 2008.), p. 7). Sanofi plans to position Multaq as the successor to its gold standard treatment Cordarone (amiodarone), which lost patent protection in 2002. Spek said Sanofi will use its existing sales force to market Multaq to targeted vascular medicine internists and specialists. "We have a lot of synergies with our existing portfolio, if you think about Plavix or ... Aprovel where we see those target groups anyway," he explained. The latest NDA filing is backed by new data from the 4,628-patient, placebo-controlled ATHENA study, a 12-month follow up to studies submitted the first time around (2 (Also see "Sanofi Dronedarone Re-Filing Anticipated In 2008 After FDA “Non Approvable” Letter" - Pink Sheet, 31 Aug, 2006.)). ATHENA showed Multaq, given in tandem with standard rate-control and antithrombotic drugs, reduced risk for atrial fibrillation/atrial flutter patients for cardiovascular hospitalization or death from any cause by 24 percent (p=0.0000002) (3 (Also see "Sanofi-Aventis Heart Drug Multaq Back To FDA In Third Quarter" - Pink Sheet, 15 May, 2008.)). Safety concerns addressed in ATHENA, Sanofi says The trial also demonstrated reduced risk of cardiovascular death (down 30 percent), arrhythmic death (down 45 percent) and first cardiovascular hospitalization (down 25 percent). Importantly, ATHENA's treatment arm saw 16 percent fewer deaths due to any cause compared to the placebo arm (p=0.17). FDA refused to file Sanofi's NDA for the compound in 2006 after an 8.1 percent death rate was posted in the Phase III ANDROMEDA trial's treatment arm, compared with a 3.8 percent death rate in the placebo arm (4 (Also see "ANDROMEDA Strain: Full Data Published From Multaq Trial" - Pink Sheet, 19 Jun, 2008.)). "We have a product which is extremely safe compared with the other products in this market," Spek said during the Aug. 8 call. "And we go into a market segment which has a heavy burden of disease." He estimated the annual disease cost burden in the U.S. to be approximately $16,000 a year per patient. While Sanofi hopes to reach market next year with its product, several other firms are trying to enter the atrial fibrillation space as well. Astellas and Cardiome just experienced a setback, however, receiving an FDA "approvable" letter for Kynapid (vernakalant) requesting additional safety data (5 (Also see "Astellas/Cardiome’s Kynapid “Approvable”" - Pink Sheet, 11 Aug, 2008.)). Solvay's Pulzium (tedisamil) also is pending at FDA, with its initial action date passed (6 (Also see "Solvay’s Pulzium Data Does Not Cross The Atlantic: FDA Panel Unanimously Opposes Approval" - Pink Sheet, 12 Dec, 2007.)). Meanwhile, Fremont, Calif.-based ARYx Therapeutics has a next-generation version of amiodarone, ATI-2042, in Phase II (7 (Also see "Vernakalant, Cardiome Limelight Could Make ARYx Glow" - Pink Sheet, 20 Mar, 2008.)). -Joseph Haas ([email protected]) |