Posted by Michael Wonder on 27 Jan 2022
Positive Early Access to Medicines Scheme (EAMS) scientific opinion awarded to GBT’s voxelotor for the treatment of haemolytic anaemia due to sickle cell disease
27 January 2022 - Global Blood Therapeutics today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has awarded a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for voxelotor, an oral once daily tablet under review by the MHRA for the treatment of haemolytic anaemia due to sickle cell disease in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea).
This positive opinion means that those patients living with sickle cell disease and meeting the eligibility criteria can gain early, pre-license access to voxelotor, while the MHRA completes its review of the marketing authorisation application.
