AbbVie Inc. (NYSE:ABBV) is working on multiple drug aspects to overcome the revenue decline due to patent cliffs as well as the induction of biosimilars in several therapeutic markets. The drugmaker has been given the green signal for its molecule, Venclyxto, indicated for the management and treatment of chronic lymphocytic leukemia (CLL), by the Committee for Medicinal Products for Human Use (CHMP).
The positive opinion is based on a conditional marketing authorization by the regulatory agency. The drug clinched orphan drug status on December 6, 2012 and will be marketed in formulations of 10 mg, 50 mg and 100 mg tablets. The molecule has shown its efficacy and safety profile in patients suffering from different varaiants of lymphocytic leukemia.
Initially, the drug was researched and developed by AbbVie and Roche Holding AG, before it got approval from the Food and Drug Administration (FDA) in the US under the trade name of Venclexta.
CLL belongs to the family of blood and bone marrow cancers and is lethal as it progresses slowly and steadily. The main function of the CHMP is to provide relief to patients suffering from fatal diseases with the launching of drugs that are in the process of development and have shown comprehensive positive results in efficacy and safety. If approved by the CHMP committee, the drug will be eligible for marketing in all 28 member countries of the European Union along with Iceland, Liechtenstein and Norway.
Noteworthy drugs include Mabthera by Roche which clinched $7,125 million with a positive median of 2.1%, Imbruvica, marketed by JNJ which racked up $689 million with 100% growth, and Gilead’s Zydelig which generated revenue of $132 million with 100% positive median in 2015.
AbbVie has to work on its drug pipeline and expansion of its drug labels in order to stand up to the fierce competition in the near future.