Trinity Announces Findings from FDA-Approved Drug Performance Index

Therapies for breast cancer, multiple myeloma, and HIV ranked the highest across audit of commercial performance, therapeutic value, and R&D complexity.

WALTHAM, Mass. – December 17, 2018 — Trinity, a leading global life science consulting firm, today announced the findings of its third annual Trinity Drug Index which assessed 57 novel drugs approved by the FDA in 2015. The index ranks drug performance against three categories: commercial performance, 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:

• Pfizer’s Ibrance, a kinase indicator indicated for breast cancer, was the best performing drug approved in 2015.
  • Ibrance was granted accelerated approval based on strong efficacy reported in Phase II and has demonstrated strong commercial performance given its first mover advantage.
• Janssen’s Darzalex and Gilead’s Genvoya ranked second and third.
  • Darzalex was the first antibody to be approved in multiple myeloma and has maximized its commercial potential by moving up the treatment paradigm through combination use.
  • Genvoya, an anti-retroviral combination therapy, lowered treatment burden for HIV patients with its once-daily dosing, thus filling unmet need.
• In 2015, there were 57 unique drug and biologic approvals, a record high in the past ~20 years, with many of these receiving expedited review designations.
• Oncology dominated FDA approvals with 15 unique products.
• Many first-in-class products were approved, spanning multiple indications in several less-prominent spaces with varying degrees of commercial success (Bridion, Strensiq, Orkambi, Kanuma, Addyi).
• Ultra-orphan drugs tended to continue to display lower commercial performance given their therapeutic value; exceptions include Orkambi and Strensiq.

“Being able to adapt to the growing complications of the drug market proves greater success.”

Leslie Sandberg Orne

“Based on this third annual index, we found commercial success to be dependent on a drug’s true clinical differentiation relative to the standard of care, or alternatively, indication expansions to widen the patient base,” said Leslie Sandberg Orne, Senior Partner at Trinity. “This is the case even when introducing new products into already crowded markets: being able to adapt to the growing complications of the drug market proves greater success.”

The index includes three case studies that provide additional context for why some products over- or under-performed commercially relative to their perceived therapeutic value. These include more information about Darzalex and Ninlaro (overperformers), Emplicity and Farydak (underperformers), Addyi (underperformer), and Praduent and Repatha (underperformers).

“Providing this evaluation of FDA-approved drugs, this report also dives into some of the intricacies of success and, perhaps more interestingly, failures in the drug market,” said Dave Fitzhenry, Managing Partner at Trinity. “This insight is especially relevant given the rise in competition, pressure around pricing, and the biosimilars market as we move forward into an era of increased innovation in science.”