Expanded FDA approval for Janssen/Pharmacyclics' Imbruvica

5 March 2016

The US Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for an additional indication, in the treatment-naïve patients with chronic lymphocytic leukemia (CLL).

The drug was jointly developed and commercialized by Janssen Biotech, a Johnson & Johnson (NYSE: JNJ) subsidiary, and Pharmacyclics, an AbbVie (NYSE: ABBV) company, who filed the supplemental New Drug Application for this indication last year (The Pharma Letter September 14, 2015).

In its recent financial results, AbbVie said sales of Imbruvica for full-year 2015 came in at $754 million, and the company has predicted peak annual sales of $7 billion for the drug. J&J posted revenues of $689 million from the drug.

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