FDA expands approval of Johnson & Johnson/Pharmacyclics' Imbruvica to Waldenstrom’s macroglobulinemia

The US Food and Drug Administration has expanded approval of Johnson & Johnson (NYSE: JNJ) and Pharmacyclics’ (Nasdaq: PCYC) Imbruvica (ibrutinib) to include the treatment of Waldenstrom’s macroglobulinemia.

This approval makes it the first drug authorized to treat the condition. The FDA’s decision was supported by data from a Phase II study of 63 patients with previously-treated Waldenstrom’s macroglobulinemia, where the therapy was associated with a 62% response rate.

Roth Capital analyst Joseph Pantginis said that the approval of Imbruvica for this indication "continues to talk to the strength of the Imbruvica franchise,” and that the drug could amass $987 million in revenue in 2015, roughly in line with guidance of about $1 billion.