Apr 29, 2016
AbbVie, a global biopharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in favor of the use of IMBRUVICA® (ibrutinib) for treating adult patients with chronic lymphocytic leukemia (CLL). This follows the approval of U.S. Food and Drug Administration (FDA) IMBRUVICA for the first-line treatment of patients with CLL on March 4, 2016. This would be the fifth treatment indication for IMBRUVICA in the EU to date if approved by the European Commission (EC).
CLL is a chronic disease. Its prevalence rate in Europe among men and women is nearly 5.87 and 4.01 cases per 100,000 persons per year, respectively. An expansion of the CLL indication in Europe would mean a larger number of CLL patients, in addition to those with the genetic mutations del 17p or TP53, could start their treatment with an effective and safe oral alternative option to chemotherapy.
“If approved by the European Commission, IMBRUVICA will be available as a treatment option for all CLL patients, including those who are treatment-naïve. The ability to offer a safe and effective, oral, single-agent alternative to chemotherapy in the first-line setting is a landmark few therapies are able to reach. The fact that IMBRUVICA has been granted this initial recommendation in the first-line setting is a testament to the dedication of those working on the compound to improve the lives of patients around the world who are suffering from CLL,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.