Strensiq (asfotase alfa)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- asfotase alfa
- Company
- Alexion Europe SAS
- Status
- Authorised
- Therapeutic area
- Hypophosphatasia
- CHMP opinion
- Wed 24 Jun 2015
- EU approval
- Fri 28 Aug 2015
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/003794
- ATC
- A16AB
- Official record
- www.ema.europa.eu
Indication
Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.
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.