MHRA grants marketing authorization for GBT's Oxbryta

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted British marketing authorization for Global Blood Therapeutics’ (GBT; Nasdaq: GBT) Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in eligible adult and pediatric patients aged 12 years and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea).

Voxelotor, an oral treatment taken once daily, is the first medicine authorized in Great Britain that directly inhibits sickle hemoglobin (HbS) polymerization, the molecular basis of sickling and destruction of red blood cells in SCD.

“We welcome the MHRA’s marketing authorization of voxelotor as a new treatment option for many people in Great Britain living with sickle cell disease, a devastating life-long condition which for far too long has seen little therapeutic innovation,” said Dr Beatriz Pujol, vice president, head of medical affairs EU & GCC at GBT, adding: “Following this marketing authorization by the MHRA, we look forward to working with the National Institute of Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) with the goal of helping to facilitate rapid access to voxelotor for people living with sickle cell disease who may benefit from this important treatment.”