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Elzonris: A Case Study In Divergent Regulatory Decisions

 
• By Ian Schofield

Stemline Therapeutics’ Elzonris was approved for a rare cancer in Europe in January, following a long and arduous two-year journey through the EU regulatory process that included an initial rejection and a subsequent re-examination by the EMA. Its fortunes were very different in the US, where the review took just six months from filing to approval.

Drug Review Profile: Elzonris
• Source: Alamy

It’s not unusual for drug regulators from different countries to take quite different stances on whether a new medicine should be approved for marketing. Stemline Therapeutics, Inc.’s orphan medicine Elzonris (tagraxofusp), whose EU authorization in January came two years after its approval in the US, is a striking example of just how far agencies’ views can diverge.

Elzonris was initially granted accelerated assessment (AA) by the European Medicines Agency, but later lost this status because the number of questions raised by

EU Drug Review Profiles

This is the latest in the Pink Sheet's series of EU drug review profiles. Previously published profiles can be accessed via the following links:

Turalio: Why The EU Said No To The US-Approved Drug

Piqray: What EU Regulators Saw And What They Wanted

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