The European Medicines Agency said Friday that its Committee for Medicinal Products for Human Use (CHMP) recommended revoking the European Union marketing authorization for Amgen's (AMGN) Tavneos after concluding that the drug's benefits no longer outweigh its risks in treating adults with severe, active granulomatosis with polyangiitis and microscopic polyangiitis.

The regulator said new information raised concerns about the reliability of the main study supporting Tavneos' approval because it did not comply with good clinical practice standards. It also concluded that data submitted in support of the original approval were inaccurate and misleading.

The European Medicines Agency said the study can no longer support the drug's effectiveness and that post-marketing data and additional analyses are insufficient to confirm its benefits.

If the European Commission confirms the recommendation, Tavneos will no longer be authorized in the European Union, the regulator said.

CHMP also recommended that no new patients begin treatment with Tavneos and that patients currently receiving the drug switch to alternative therapies, it added.