AbbVie is a research-based biopharma company, developing small molecules and biologics for the treatment of various diseases.
In 2013, Abbott Laboratories splits into two entities- Abbott, Inc., to market medical and diagnostic products and AbbVie, Inc. the research and development focused biopharma company.
- In April 2016, the FDA approved VENCLEXTA (venetoclax) a BCL-2 inhibitor for use in patients with CLL, having 17p deletion (deletion located on the chromosome 17 short arm) and were treated with at least one prior therapy. In addition, in Oct 2020 VENCLEXTA was approved by US FDA, in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who are 75 years of age or older or have other medical conditions that prevent the use of standard chemotherapy. VENCLYXTO is approved in Europe for CLL in combination with rituximab in patients who have received at least one previous treatment.
- Venclexta is marketed by both AbbVie and Genentech USA, with both companied commercializing the drug within the United States, but only AbbVie has commercialization rights outside of the U.S.
- In Feb 2014, U.S. FDA granted accelerated approval to IMBRUVICA (ibrutinib) an oral, once-daily, Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) who received at least one prior therapy.
- In the United States ibrutinib is indicated for the treatment of adults with mantle cell lymphoma (MCL) who have received at least one prior therapy, adults with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with or without 17p deletion, adults with Waldenström’s macroglobulinemia (WM), adults with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy, adults with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
- In Dec 2011, Johnson & Johnson and Pharmacyclics (now part of AbbVie) agreed to co-develop ibrutinib/PCI-32765 and J&J paid Pharmacyclics $150 Mn upfront and $825 Mn in milestones. Under the terms, both Pharmacyclics and Janssen to book revenue, Pharmacyclics in the US and Janssen in the rest of the world, while profits was to be shared 50/50 worldwide.
- The drug was originally developed by TAP Pharmaceuticals, a joint venture between Abbott and Takeda, later in 2008 the joint venture was dissolved and TAP pharma merged with Takeda.
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