Clinical Trial Updates (SCD)

L-glutamine

Update: 30 June 2021

  • The Saudi Food and Drug Authority (SFDA), in Saudi Arabia, will review the oral medication Endari(L-glutamine) for treating sickle cell disease (SCD). Given that the SFDA’s review process typically takes 12 to 18 months, a decision is not expected before mid-to late-2022. Meanwhile, Endari will be available to eligible SCD patients in the Kingdom of Saudi Arabia on an early access basis to address an unmet medical need.
  • The medicine gained approval in Israel in June 2020.
  • Endari has been approved in the USA since 2017 to treat severe SCD complications in adults and children, ages 5 and older.
  • In the face of a negative opinion from the European Medicines Agency (EMA) over efficacy doubts, Emmaus Life Sciences has withdrawn its marketing application in 2019.
  • As the company seeks other regulatory pathways within the EMA, Xyndari (EU name) is currently, available through early access programs in a number of European Union member states, as well as in Turkey, the Middle East, and South America.

Source: https://sicklecellanemianews.com/2021/06/01/endari-sickle-cell-therapy-emmaus-now-under-review-saudi-arabia/

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