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AbbVie's Venclexta Receives Accelerated Approval From FDA, Stock Ticks Higher

AbbVie's Venclexta Receives Accelerated Approval From FDA, Stock Ticks Higher

Shares of AbbVie Inc (NYSE: ABBV) were trading higher by nearly 2 percent early Tuesday morning after the company announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of Venclexta.

Venclexta, a table taken orally, is used for the treatment of patients diagnosed with chronic lymphocytic leukemia.

AbbVie noted that the FDA's accelerated approval decision was based on an overall response rate in a Phase 2 clinical study in patients with 17p deletion. The company added that continued approval from the FDA may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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AbbVie further stated it expects Venclexta to become commercially available in the United States within one week.

"The FDA's approval of Venclexta marks a major milestone for our company, and more importantly for the patients diagnosed with relapsed/refractory CLL who harbor the 17p deletion," said Richard Gonzalez, chairman of the board and chief executive officer of AbbVie. "BCL-2 inhibition is a novel mechanism which brings a new treatment option to patients who need additional therapies."

"The approval of Venclexta as a first-in-class BCL-2 inhibitor gives physicians an important option for the treatment of relapsed/refractory CLL harboring the 17p deletion," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "With the efficacy observed in this patient population, Venclexta has the potential to be an important and new therapy, advancing our efforts to bring novel treatment options to patients with this type of cancer."

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