Pulled From EU Assessment Process: Orphan Drugs For Kidney Disease, Mesothelioma

Two orphan medicines have been withdrawn from the evaluation process at the European Medicines Agency, one of them for recurrent nephrotic syndrome, the other for mesothelioma. Three products are undergoing a re-evaluation after an initial negative opinion from the CHMP.

Lung radiography
An orphan drug for mesothelioma is one of two products withdrawn from the CHMPassessment process

The European Medicines Agency committee that recommends new drugs for EU approval, the CHMP, delivered no negative opinions on June 23 following its monthly meeting, but two products were withdrawn from the evaluation process – both of them orphan medicines for rare diseases. The committee also announced that it was planning to re-examine three negative opinions that it adopted at its meeting in May.

One of the drugs that was withdrawn from the evaluation process was ACE Pharmaceuticals’ Elmisol (levamisole) tablets, which had been...

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