EP Vantage FDA Approval Rates

Niche Products Driving Record Success


EP Vantage report FDA Approval Rates: Niche Products Driving Record Success, based on market intelligence and analysis from EvaluatePharma, shows that a focus on hard to treat or specialist diseases is set to result in record post-launch sales for new drugs in 2013. While the total tally of approved drugs and biologics for 2013 is not forecast to match last year's record of 43, the combined US sales for this year's approved products could surpass $18bn five years after launch.     

 Key findings include:

  • Since January 1, to November 11, 2013 the FDA has approved 27 new compounds with another seven hopefuls awaiting approval.
  • Of the 27 drugs approved so far, combined fifth-year U.S. sales are forecast to reach $13.9bn.
  • Tecfidera ranks No. 1 among top five approvals of 2013 (January to November, 11) with sales estimated at $2.9bn by 2018.
  • If approved in 2013, Gilead Sciences’ sofosbuvir stands to become this year’s most valuable new molecule, with fifth-year US sales estimated at almost $3bn.

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