Janssen: We are working with the FDA

US-based Janssen reveals a few details about what has happened with a phase I study of a candidate developed on Genmab’s DuoBody platform that was put on clinical hold by the US FDA recently.

Foto: Janssen PR

It was a single serious incident with a patient that spurred the US FDA to put a clinical hold on a study with a drug from US-based pharma group Janssen recently - a drug that has been developed on its Danish biotech partner Genmab’s DuoBody platform.

“It had to do with one patient, but we are not going to give any more information about it for the time being,” Kellie McLaughlin, Therapeutic Area Communications Lead, Oncology for Janssen’s parent company Johnson & Johnson, tells MedWatch.

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As reported earlier, the phase I study with candidate JNJ-63709178 in acute myeloid leukemia  (AML) was put on clinical hold because a serious adverse event (SAE) had been registered in the trial , which meant patient recruitment had also been put on hold.

 Serious setback for Genmab in DuoBody collaboration 

Kellie McLaughlin explains that Janssen put the study on temporary standby and informed the FDA as soon as the company was made aware of the SAE. It then discussed the incident with the agency and about a week later, on August 16th, the FDA put the study on clinical hold.

“We are now working with the FDA to address the recommended changes to the study. We are evaluating all aspects of the study with the FDA. With the guidance of the FDA we hope to resume this study. Once the status of the study changes it will be detailed on,” says Kellie McLaughlin.

- translated by Martin Havtorn Petersen

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