Evkeeza (evinacumab)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- evinacumab
- Company
- Ultragenyx Germany GmbH
- Status
- Authorised
- Therapeutic area
- Hypercholesterolemia
- CHMP opinion
- Thu 22 Apr 2021
- EU approval
- Thu 17 Jun 2021
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005449
- ATC
- C10AX
- Official record
- www.ema.europa.eu
Indication
Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.