Clinical Trial Updates (SCD)

Xromi

 

Update: 30 June 2021

No update available

 

Update: 08 January 2021

No update available

 

Update: 05 November 2020

No update available

 

Update: 25 August 2020

No update available.

 

Update: 31 May 2020

No update available.

 

Update: 31 March 2020

No update available.

 

Update: 31 January 2020

No update available

 

Update: 25 November 2019

  • The Phase 3 RESET trial testing the effectiveness and safety of Rivipansel(GMI-1070),  to treat vaso-occlusive crisis (VOC) in hospitalized patients with sickle cell disease (SCD), failed to reach both its primary and secondary goals, top-line study results show.

Sources: https://sicklecellanemianews.com/2019/08/06/rivipansel-for-vaso-occlusive-crisis-in-scd-fails-to-meet-goal-in-phase-3-trial/

 

Update: 27 September 2019

Granted marketing authorisation in the EU.

Xromi is a hybrid medicine of Hydrea which has been authorised in the EU since 29 May 1986. Xromi contains the same active substance as Hydrea but is authorised for a different indication. Hydrea is authorised for the treatment of certain cancers.

With new supportive data, Xromi is intended for the prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age, to be available as a 100 mg/ml oral solution.

The active substance of Xromi is hydroxycarbamide.

Sources: https://www.ema.europa.eu/en/medicines/human/EPAR/xromi

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/xromi

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