AbbVie, Amgen, and UCB Lead Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from AbbVie, Amgen, and UCB.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday July 11, 2018 to Tuesday July 17, 2018.
AbbVie Submits sNDA to FDA for Leukemia Drug Venetoclax
AbbVie has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for venetoclax, an oral B-cell lymphoma-2 inhibitor, in combination with a hypomethylating agent or in combination with low-dose cytarabine for treating newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
If approved in AML, venetoclax would be available for use in two blood cancers, chronic lymphocytic leukemia (CLL) and AML. Venetoclax recently received expanded approval in the US for use alone or in combination with rituximab for treating relapsed/refractory (R/R) CLL or small lymphocytic lymphoma patients, with or without 17p deletion, who have received at least one prior therapy.
Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the US and by AbbVie outside of the US.
Amgen, UCB Resubmit BLA for Osteoporosis Drug Evenity to FDA
Amgen and UCB have resubmitted their biologics license application (BLA) to the US Food and Drug Administration (FDA) for Evenity (romosozumab), an investigational monoclonal antibody for treating osteoporosis in postmenopausal women at high risk for fracture. The resubmission follows the companies’ receipt of a Complete Response Letter (CRL) for the drug’s BLA originally submitted last year (2017).
In July 2017, the FDA issued a CRL for the Evenity BLA. The original submission included data from Phase III placebo-controlled study of postmenopausal women with osteoporosis. With the availability of data from a Phase III active-comparator study, the agency asked that the efficacy and safety data from the study be integrated into the application. The resubmission was also requested to include the efficacy and safety data from a Phase III trial evaluating Evenity in men with osteoporosis.
Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop, and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on developing romosozumab for treating osteoporosis. The drug is designed to work by inhibiting the activity of sclerostin, which enables Evenity to increase bone formation and reduce bone resorption simultaneously, according to Amgen.
The European Medicines Agency and the Pharmaceuticals and Medical Device Agency in Japan are currently reviewing marketing applications for Evenity and interactions with the agencies are ongoing.