Label change

Tirzepatide profile updated for obstructive sleep apnea approval

We added obstructive sleep apnea as an A-graded, FDA-approved indication for tirzepatide following the SURMOUNT-OSA trials.

What happened

We updated the tirzepatide profile to reflect its approval for moderate-to-severe obstructive sleep apnea in adults with obesity, and graded that outcome A — Established on the basis of the SURMOUNT-OSA program, which showed meaningful reductions in the apnea-hypopnea index.

Why it matters

This is the first incretin drug approved for OSA, and it broadens tirzepatide’s evidence base beyond weight and glycemic outcomes. It does not change the cardiovascular grade, which remains C pending the dedicated SURPASS-CVOT outcomes trial.

Affected compounds

References

  1. FDA Prescribing Information — Zepbound (tirzepatide)

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