Xyndari

glutamine

Opinion

Update of 27 June 2019:

The applicant for Xyndari has requested a re-examination of the CHMP’s May 2019 opinion. Upon receipt of the grounds of the request, the CHMP will re-examine its opinion and issue a final recommendation.

On 29 May 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Xyndari, intended for the treatment of sickle cell disease.

The company that applied for authorisation is Emmaus Medical Europe Limited. It may request a re‑examination of the opinion within 15 days of receipt of notification of this negative opinion.

Key facts

Name
Xyndari
Agency product number
EMEA/H/C/004734
International non-proprietary name (INN) or common name
  • glutamine
Active substance
  • glutamine
Therapeutic area
Anemia, Sickle Cell
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
29/05/2019
Company name
Emmaus Medical Europe Ltd
Status
Negative
Application type
Initial authorisation

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