AbbVie Gets European Medicines Agency's Positive Opinion For Its IMBRUVICA

AbbVie Inc ABBV disclosed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for use of its IMBRUVICA. The drug was for the treatment of adult patients with previously-untreated chronic lymphocytic leukemia (CLL) in the region.

According to the company, the favorable CHMP recommendation came on the heels of the FDA in the United States issuing approval on March 4 for its IMBRUVICA for the first-line treatment of patients. The drug firm said that if the European Commission approves the drug, it would be the fifth treatment for IMBRUVICA in the region.

AbbVie's EVP for R&D and Chief Scientific Officer, Michael Severino said, "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."

He added, "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."

On Friday, the stock traded 0.5 percent down.