December 2021 batch of EMA/CHMP recommendations

18 December 2021

On Friday, the European Medicines Agency’s human medicines committee (CHMP) announced recommendations of novel medicines for approval at its December 2021 meeting.

USA-based Global Blood Therapeutics’ (Nasdaq: GBT) Oxbryta (voxelotor) was granted a positive opinion for the treatment of hemolytic anemia due to sickle cell disease. Oxbryta was supported through EMA’s Priority Medicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs.

A positive opinion was adopted for US pharma giant Pfizer’s NYSE: PFE) Ngenla (somatrogon) to treat growth hormone deficiency in adolescents and children from three years of age.

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