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Elsevier Business Intelligence
Pharmaceutical Approvals Monthly
From the editors of
“ The Pink Sheet”
R E G U L AT O R Y A F FA I R S & C L I N I C A L D E V E L O P M E N T Vol. 16, No. 3
MARCH 2011
TOP STORIES
PIPELINE UPDATES
Drug Review Profile Jevtana Review Shows Power Of A Survival Advantage Sanofi-Aventis’ hormone-refractory prostate cancer therapy Jevtana sprinted through FDA approval despite toxicity issues. But Jevtana also offered the first survival advantage shown in docetaxel-experienced HRPC. Survival data, unmet medical need, and FDA’s ability to require studies of a lower dose that could reduce toxicity enabled the expedited review . . . . . . . . . . . . . . . . . . 33
R&D News How A Biomarker Revived Synta’s Cancer Drug Elesclomol Two years ago, Synta’s elesclomol flamed out in Phase III and GSK walked out on its partnership. Today the drug is back in Phase II – thanks to Synta’s relentless investigation into why the trial failed. The firm found patients with high levels of the enzyme LDH died earlier; high LDH is linked to hypoxia, and elesclomol has less activity in low oxygen conditions. A cheap LDH test is already widely available, allowing more targetted trial enrollment . . . . . . . . . . 22
FDA Policy Changes To REMS Policy? The number of products approved with REMS could plunge if FDA adopts a draft guidance proposing to make Medication Guides “in most cases” a part of REMS only when elements to ensure safe use are also required . . . . . . . . . . . . . . . . . . 15
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Efficacy Supplement Numbers On The Rise As Industry Braces For Patent Cliff SHIRLEY HALEY s.haley@elsevier.com
D
rug makers are squeezing more new and expanded indications out of approved drugs to compensate for patent expiries and the lagging pace of new drug approvals, according to an analysis from the Tufts Center for the Study of Drug Development. The findings provide quantification of the general perception that as innovation disappoints and the patent cliff approaches, pharmaceutical companies have been focusing on lifecycle management for existing brands. The total number of efficacy supplement approvals was up 17% in the period of 2004-2009 over the 1998-2003 period, CSDD reports. More than half of the new drugs approved between 1998 and 2009 had more than one supplemental approval, and one in eight of those had six, including a small number (9%) gained through a new NDA (which would be needed for applications with a major new use with extensive clinical data or formulation work). The report is derived from an examination of 889 efficacy supplements using information from the center’s own database along with data from FDA. Continued > Page 4
FDA PERFORMANCE TRACKER User Fee Goals For Recently Announced NDA/BLA Submissions .........................................27 NDAs/BLAs With User Fee Goals In February, March, April ..................28 Recently Announced “Complete Response” Letters...............................18 New Molecular Entities Approved In 2011 .................................14 Biologics Approved In 2011 ..............14
Recent Risk Evaluation & Mitigation Strategies ..........................16 2011 FDA Advisory Committee Recommendations ..............................18 February Full Approvals.....................10 February Supplemental Approvals ................................................ 6 February Abbreviated Approvals ................................................ 11
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