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the face of a negative opinion from the European Medicines Agency (EMA) over efficacy doubts, Emmaus Life Sciences has withdrawn its marketing application in 2019.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.