Trinity Reveals Findings on FDA-Approved Novel Drug Performance

Trinity, a leading global life sciences consulting firm, today announced the findings of its second annual Trinity Drug Index which assessed all novel drugs approved by the FDA in 2014. The index ranks drug performance against three categories: commercial success, therapeutic value and R&D complexity, assigning each drug a score in those three areas as well as an overall composite score.

Top findings of this year’s Trinity Drug Index include:

      • Immuno-oncology agent Keytruda was the best performing drug approved in 2014, followed by Harvoni and Opdivo.
      • To be successful, mass-market, primary care products had to demonstrate at least moderate therapeutic innovation coupled with substantial marketing power. · While several orphan drugs achieved high commercial scores, others (mainly, “ultra-orphans”) were not able to reap the success expected based on their therapeutic value.
      • Of products acquired during the regulatory review process or after FDA approval (Esbriet, Northera, Dalvance, Sivextro, and Zerbaxa), all but Esbriet underperformed commercially.
      • Anti-infective agents did not perform well commercially despite average to above average therapeutic scores.

      “Most of the top performers are innovative specialty drugs targeting multiple niche indications with high unmet needs,” said John Corcoran, Founder and President, Trinity. “With increasing competition and tighter payer and regulatory controls, it’s critical that companies prioritize their investment to ensure an optimal return.”

      • To shed light on why products over- or under-perform commercially relative to their therapeutic value, the index authors included three case studies. These include a look at Keytruda and Opdivo (overperformers), Zerbaxa (underperformer), and Vimizim and Zykadia (underperformers).

      “Even with the unique challenges presented by certain markets, success can be achieved in all therapeutic areas,” said Neal Dunn, Partner, Trinity. “The key to executing a winning clinical and commercial strategy is to clearly and effectively demonstrate the value of novel agents.”


See all Thought Leadership posts