CHMP Highlights: No For Xyndari, Edaravone MAA Pulled And Good News For Univar’s Cufence

This month’s meeting of the European Medicines Agency’s CHMP appears to have been eventful. One marketing authorization application was rejected, one was pulled, and an earlier negative opinion was upheld. Four MAAs were recommended for approval, including a new treatment from Univar for Wilson’s disease.

It was approved in the US in 2017 but EU regulators say Emmaus Life Sciences’ sickle cell disease therapy, Xyndari (oral glutamine), should not be allowed on the market in Europe.

Xyndari was one of six new medicines that were up for an opinion this week from the European Medicines Agency's scientific committee, the CHMP, on whether or not they should be approved for sale across the EU. Emmaus says it will seek a re-examination of the negative opinion

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