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Amgen's Parsabiv's EU Approval Contrasts With US FDA Rejection

 
• By Sten Stovall

Follow-on hyperparathyroidism product likely needs to resolve safety issues with US agency, analysts say, but extensive data package, including a head-to-head trial, has satisfied European regulators.

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Amgen Inc.’s Mimpara (cinacalcet) follow-on Parsabiv (etelcalcetide) has been waved through in the EU despite it hitting a US regulatory hurdle, but analysts believe the US FDA will eventually approve the drug – despite likely safety concerns – for treating secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Parsabiv had seemed set for a smooth regulatory review in the US with a data package made up of three...

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