AbbVie, Janssen’s Imbruvica gets European approval to teat CLL

pharmafile | May 31, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing AbbVie, CLL, drug trial, regulation 

AbbVie (NYSE: ABBV) on Tuesday said Imbruvica (ibrutinib) has secured European regulatory backing to treat chronic lymphocytic leukemia or CLL.

This is the fifth indication for the drug in the EU, which is co-developed by Janssen and AbbVie.

The latest approval is an expansion upon the initial EC approval in October 2014 for certain patients with CLL, the company said in a statement.

AbbVie has the rights to market Imbruvica in EMEA (Europe, Middle East and Africa) as well as the rest of the world, while Janssen markets it in the US.

The approval was based on data from the Phase III trials. The drug showed significant improvement in several efficacy endpoints versus chlorambucil. Specifically, Imbruvica showed 90% progression-free survival rate versus 52% for chlorambucil. In addition, Imbruvica showed statistically significant prolonged overall survival.

Anjali Shukla

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