POSITIVE CHMP OPINION SUPPORTS BROADER USE OF AMGEN'S REPATHA® BEFORE A FIRST HEART ATTACK OR STROKE
Amgen announced that the EMA's CHMP adopted a positive opinion for Repatha to reduce cardiovascular risk in adults at high risk without a prior heart attack or stroke. The recommendation is based on the Phase 3 VESALIUS-CV trial of over 12,000 patients, which showed a 25% relative reduction in the risk of major adverse cardiovascular events and a 36% reduction in heart attack risk.
Key figures
- Drug Name
- Repatha (evolocumab)
- Phase Of Trial
- Phase 3
- Patients enrolled
- more than 12,000
- Trial duration years
- 4.6
- Global patients treated
- more than 10 million
- Ldl c median placebo mg dl
- 109
- Risk reduction 3 point mace
- 25%
- Risk reduction 4 point mace
- 19%
- Risk reduction heart attack
- 36%
- Ldl c median treatment mg dl
- 45
AI analysis
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