Blockbuster Drug Imbruvica Gets Expanded FDA Approval for Chronic Graft Versus Host Disease

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A blockbuster drug is about to get a chance to have even higher sales. The U.S. Food and Drug Administration (FDA) has expanded its approval of Imbruvica for the treatment of adult patients with chronic graft versus host disease (GVHD) after failure of one or more treatments. What matters about this approval was noted in the FDA press release as being the first FDA-approved therapy for the treatment of chronic GVHD.

AbbVie Inc. (NYSE: ABBV) is behind Imbruvica via its Pharmacyclics unit. AbbVie already released its earnings in late July, and its report noted that Imbruvica is jointly developed and commercialized with Janssen Biotech under Johnson & Johnson (NYSE: JNJ).

According to the Rare Diseases Network, patients who have had a blood or marrow stem cell transplant from another person can get chronic GVHD. That group also noted that chronic GVHD usually begins later after transplant and lasts longer than acute GVHD. Prednisone or other similar anti-inflammatory or immunosuppressive medications are used to treat chronic GVHD. Other immunosuppressive medications can be used if treatment with prednisone is not successful.

According to Abbvie’s earnings release at the end of July, its global net sales of Imbruvica were $626 million in the second quarter alone, representing a gain of 42.6%. That was represented by AbbVie as $528 million in U.S. sales and international profit sharing of $98 million for the quarter. AbbVie showed that it has already generated $1.177 billion in Imbruvica sales in the first half of 2017, up 39% from the first half of 2016.

Johnson & Johnson already has released its second-quarter earnings as well, and it broke out data on Imbruvica. Its second-quarter Imbruvica sales were listed as $450 million globally, with $248 million tied to international sales and $202 million tied to U.S. sales. That was up 52.5% from a year ago on a combined global basis.

This expanded approval for Imbruvica adds to its targets. Imbruvica is a kinase inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and for CLL/SLL with 17p deletion.

The Imbruvica website shows that approximately 4% to 10% of patients discontinued use of Imbruvica due to adverse reactions (most common were pneumonia, hemorrhage, atrial fibrillation, rash and neutropenia. It also noted that approximately 6% of patients had a dose reduction due to adverse reactions.

Expanded uses of drugs can help smaller companies, but AbbVie already has a market cap of $112 billion and Johnson & Johnson has a monster market value of $354 billion.