Oxbryta

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Voxelotor

Authorised
This medicine is authorised for use in the European Union.

Overview

Oxbryta is a medicine used to treat haemolytic anaemia (excess breakdown of red blood cells) in patients aged 12 years and older who have sickle cell disease. Oxbryta can be given on its own or together with another medicine for sickle cell disease called hydroxycarbamide.

Sickle cell disease is a genetic disease where individuals produce an abnormal form of haemoglobin (the protein in red blood cells that carries oxygen). The red blood cells become rigid and sticky, and change from being disc-shaped to being crescent-shaped (like a sickle). Sickle cell disease is rare, and Oxbryta was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 November 2016. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu-3-16-1769.

Oxbryta contains the active substance voxelotor.

This EPAR was last updated on 13/04/2022

Authorisation details

Product details
Name
Oxbryta
Agency product number
EMEA/H/C/004869
Active substance
Voxelotor
International non-proprietary name (INN) or common name
Voxelotor
Therapeutic area (MeSH)
  • Anemia
  • Anemia, Hemolytic
  • Anemia, Sickle Cell
Anatomical therapeutic chemical (ATC) code
B06AX03
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Global Blood Therapeutics Netherlands B. V.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
14/02/2022
Contact address

Strawinskylaan 3051
1077ZX Amsterdam
The Netherlands

Product information

12/04/2022 Oxbryta - EMEA/H/C/004869 - IAIN/0001

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other hematological agents

Therapeutic indication

Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Assessment history

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