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Pharmaceutical industry

FDA Raises Concerns Over AstraZeneca's Onglyza Ahead of Safety Meeting

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) has raised concerns over AstraZeneca's diabetes drug Onglyza ahead of a committee meeting to discuss the safety of a class of drugs called DPP-4 inhibitors. An FDA briefing document pointed to increases in all-cause mortality among patients taking Onglyza, particularly due to heart failure. In contrast, a review of data on Takeda's Nesina found no significant increase in mortality risk. The FDA's concerns come as Merck's top-selling DPP-4 treatment Januvia is set to be tested in an outcomes trial, with results expected at this summer's American Diabetes Association meeting.

Key Takeaways:

  • The FDA has raised concerns over AstraZeneca's Onglyza due to increased all-cause mortality among patients taking the drug, particularly from heart failure.
  • Data on Takeda's Nesina showed no significant increase in mortality risk, alleviating some concerns over the DPP-4 inhibitor class.
  • Merck's Januvia, the top-selling DPP-4 treatment, is set to be tested in an outcomes trial, with results expected at this summer's American Diabetes Association meeting.
  • The stakes are high for the DPP-4 class, with investors fearing a labeling change or even a loss of billions in value if Januvia's outcomes trial results are unfavorable.
  • Merck is developing a weekly DPP-4 blocker called omarigliptin and has partnered with Pfizer to develop a fixed-dose combination of a DPP-4 blocker and the Phase III-stage ertugliflozin.

Statistics:

  • AstraZeneca's shares fell nearly 2% on Friday in response to the FDA briefing.
  • The potential loss in value for the DPP-4 class if Januvia's outcomes trial results are unfavorable is estimated in the billions.
  • 60 million: The deal amount between Merck and Pfizer for the rights to ertugliflozin.
  • 2013: The year Merck struck the deal with Pfizer for the rights to ertugliflozin.

Sources:

  • Damian Garde, The FDA raised some alarming concerns tied to AstraZeneca's ( ) ahead of a committee meeting to discuss the safety of so-called DPP-4 inhibitors... - Bloomberg

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