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Home Industry News ZymoGenetics and Merck Serono receive FDA assessment for atacicept study

ZymoGenetics and Merck Serono receive FDA assessment for atacicept study

5th October 2007

ZymoGenetics and partner Merk Serono have mutually announced that they have come to an agreement with the US Food and Drug Administration (FDA) on a Special Protocl Assessment (SPA) for an atacicept clinical trial.

Following the agreement the two companies will push ahead with conducting a trial investigating the new drug in the treatment of patients with lupus nephritis.

The trial is intended to demonstrate the efficacy and safety of atacicept and is expected to be conducted at sites around the world with around 200 patients with active lupus nephritis to be enrolled.

Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, confirmed that an SPA was the “clearest path” in ensuring that the trial will support an application for marketing authorisation.

“We’re pleased to have reached agreement with the FDA about the design of this study and plan to begin enrolling patients in the fourth quarter of 2007.”

Another clinical trial will be undertaken to form part of the application for marketing authorisation of atacicept.

Merck Serono is the division of Merck KGaA which specialises in innovative prescription pharmaceuticals.

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