AbbVie’s venetoclax accepted for EU and US regulatory review

AbbVie has announced that its new chronic lymphocytic leukaemia (CLL) therapy venetoclax has been accepted for review by regulators in the US and Europe.

The US Food and Drug Administration and European Medicines Agency have both accepted the company's applications for the drug, which is intended for the treatment of CLL in adults who have received at least one prior therapy, including patients with 17p deletion.

An inhibitor of the B-cell lymphoma-2 (BCL-2) protein developed in partnership with Genentech and Roche, venetoclax has demonstrated its safety and efficacy in a phase II open-label study.

In the US, the drug has received priority review status, underlining its potential to address unmet medical needs.

Dr Michael Severino, executive vice-president of research and development and chief scientific officer at AbbVie, said: "Patients are always our number one priority and we accelerated our efforts to bring venetoclax, the first BCL-2 inhibitor, to patients with CLL in need of new therapies."

Last week, the company announced the commencement of a phase III clinical trial programme evaluating ABT-494, its new treatment of rheumatoid arthritis.