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AbbVie Inc (NYSE:ABBV) Updates On Key Events From The Third Quarter

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AbbVie Inc (NYSE:ABBV) reported that the Phase III MURANO trial of VENCLEXTA/VENCLYXTO tablets in combination with Rituxan achieved its primary endpoint. Data demonstrated that VENCLYXTO/VENCLEXTA in combination with Rituxan extended progression-free survival in people with refractory/relapsed chronic lymphocytic leukemia versus a combination of Rituxan and bendamustine.

Safety data, including grave and most common discontinuation rates and adverse events, are currently being evaluated. Full data from this trial will support regulatory submissions, and will be showcased at an imminent medical conference. VENCLYXTO/VENCLEXTA is being advanced by Genentech and AbbVie.

The highlights

AbbVie announced the U.S. FDA permission for IMBRUVICA as a treatment for adult patients with cGVHD after non-performance of one or more lines of systemic treatment. IMBRUVICA is the only therapy specifically permitted for adults with cGVHD, a grave and debilitating potential consequence of bone marrow or stem cell transplant. This indication is the primary for IMBRUVICA outside of oncology, and the sixth U.S. ailment indication for IMBRUVICA. It should be noted that IMBRUVICA is jointly advanced and commercialized with Janssen Biotech, Inc.

In the third quarter, AbbVie reported that MAVIRET/MAVYRET, a pan-genotypic treatment for people with chronic hepatitis C virus infection, obtained regulatory nod from the FDA, the Japanese Ministry of Health, Labor & Welfare, and the European Commission.

The company, in cooperation with Neurocrine Biosciences, Inc., reported that the FDA allowed priority assessment for elagolix, an investigational, orally given gonadotropin-releasing hormone antagonist, being assessed for the management of endometriosis with related pain.

In two replicate Phase III clinical trials, elagolix showed superiority compared to placebo in lowering three types of endometriosis-related pain – non-menstrual pelvic pain, painful intercourse and daily menstrual pelvic pain. If approved by the U.S. FDA, elagolix will mark as the first new medical management treatment alternative for endometriosis-associated pain in over a decade.

In the last trading session, the stock price of AbbVie declined 0.78% to close the day at $90.25.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of journaltranscript.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure

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