The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Trends Update — Comparative Effectiveness: To Head-to-Head or Not To Head-to-Head?

Goats_butting_heads_in_GermanyOne of the challenges of comparative effectiveness implementation is figuring out when to look for comparative data. Two developments this week shed light on current comparative effectiveness thinking by regulators and pharma:

  1. Vanda’s new antipsychotic, iloperidone (Fanapt) was approved by the FDA last week without any head-to-head comparison against competitors (Zyprexa, Risperidol).  This approval indicates that so far, as the In Vivo Blog points out, the FDA is sticking to the view expresed by Bob Temple last year to the RPM Report that “[i]n most settings, especially for symptomatic treatments, we [the FDA] do not get or ask for comparative data and are perfectly willing to approve a drug that is shown effective.” (emphasis added).
  2. Nevertheless, reports today indicate that AstraZeneca decided to find out at Phase III whether its heart drug Brilinta is more effective than Plavix.  AZ conducted one of the largest head-to-head studies ever undertaken before regulatory approval.  FierceBiotech says that “offers a clear indication of the path developers will be more willing to take as they angle for market share among increasingly cost-conscious payers.”

Would Vanda have had an easier time if it had done a head-to-head trial? Could they have sustained the company long enough to find out? Maybe the only moral of these two trials is to look for comparative data as soon as you can afford to.

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