Zokinvy (lonafarnib)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- lonafarnib
- Company
- Integral Pharma Solutions EU Limited
- Status
- Authorised
- Therapeutic area
- Progeria; Laminopathies
- CHMP opinion
- Thu 19 May 2022
- EU approval
- Mon 18 Jul 2022
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005271
- Official record
- www.ema.europa.eu
Indication
Zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of Hutchinson-Gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous LMNA mutation with progerin-like protein accumulation or a homozygous or compound heterozygous ZMPSTE24 mutation.
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.