AbbVie (ABBV, Financial) announced April 4 that its supplemental New Drug Application, with which the Lake Bluff, Illinois-based worldwide pharmaceutical company is looking for approval of Imbruvica (ibrutinib) for the treatment of patients affected with chronic graft-versus-host-disease (GVHD), has been granted a review by the Food and Drug Administration (FDA).
If the FDA approves the company’s application, AbbVie’s Imbruvica will be the first drug used in the U.S. to treat patients who are suffering from chronic GVHD.
The graft-versus-host-disease is a pathological condition that occurs after a stem cell or bone marrow transplant has a reaction of the donor’s immune cells versus host tissues. The donor cells see the recipient’s organs as foreign and attack them, causing damage to the skin, liver and digestive tract. The chronic form of this pathological condition usually starts a few months after a stem cell or bone marrow transplant. Considering the number of transplants performed, it is estimated that the number of patients who develop acute GVHD will “increase over time and 30% to 70% of post-allogeneic transplant patients will develop cGVHD,” the company says, adding that there are “no therapies specifically approved for patients with cGVHD in the U.S. who have failed first-line corticosteroid therapy and require additional therapy.”
Generally, doctors use steroids or other drugs to alleviate the immune system cells’ attack, but in many cases these drugs do not work and the condition becomes life threatening for the cGVHD patient.
Lori Styles, M.D., Pharmacyclics' (FRA:PY2, Financial) senior medical director and leader of the GVHD clinical program, commented, "This regulatory filing is meaningful as it signifies the first potential indication for ibrutinib outside of hematological malignancies in a disease that severely impacts the patient's quality of life. We are pleased that these patients now have the potential for an effective treatment option."
Pharmacyclics is a subsidiary company of AbbVie.
AbbVie is trading around $65.11 per share with a price-sales (P/S) ratio of 4.05 and a price-book (P/B) ratio of 22.37. The forward price-earnings (P/E) ratio is 10.07, and the Enterprise Value/EBITDA ratio is 12.24. The dividend yield is 3.93%.
Disclosure: I have no positions in any stock mentioned in this article.
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