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Key Developments: AbbVie Inc (ABBV.K)

ABBV.K on New York Consolidated

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Latest Key Developments (Source: Significant Developments)

AbbVie Inc's VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval in Japan for the Treatment of Genotype 1 Chronic Hepatitis C
Monday, 28 Sep 2015 02:00am EDT 

AbbVie Inc:Abbvie's viekirax® (ombitasvir/paritaprevir/ritonavir tablets) receives approval in Japan for the treatment of genotype 1 chronic hepatitis c.New interferon and ribavirin-free treatment option for patients with most common type of hepatitis in Japan, genotype 1 chronic hepatitis c.  Full Article

AbbVie to advance Once-Daily ABT-494 to phase 3 in Rheumatoid Arthritis by Year-End
Friday, 25 Sep 2015 07:13am EDT 

AbbVie Inc:Says to opt-out of collaboration with Galapagos on filgotinib.Following a thorough review of available data, AbbVie will not exercise its right to in-license the Galapagos JAK1 inhibitor, filgotinib.Per the terms of the agreement with Galapagos, all rights to filgotinib will revert solely to Galapagos.  Full Article

AbbVie Inc's ABT-494 meets primary endpoint in two phase 2 studies in Rheumatoid Arthritis
Friday, 25 Sep 2015 07:08am EDT 

AbbVie Inc:Announced results from two Phase 2 clinical trials evaluating its investigational selective JAK1 inhibitor, ABT-494, in patients with inadequate response to either methotrexate or TNF inhibitors.Clinical trials, BALANCE-I and BALANCE-II, achieved ACR20 at week 12 across all dose levels, except the lowest dose in BALANCE-II.Intends to move rapidly to Phase 3 studies of ABT-494 by the end of 2015 with a once-daily formulation.Says the primary endpoint of both studies was ACR20 response at week 12.In the TNF-inadequate responder population, ACR20 responses up to 73 percent and ACR50 responses up to 44 percent.In the MTX-inadequate responder population, ACR20 responses up to 82 percent and ACR50 responses up to 50 percent.Says overall rates of discontinuation and serious adverse events were <5% and <3%, respectively, across both studies.  Full Article

AbbVie Inc plans to proceed to phase 3 evaluation of elagolix in patients
Wednesday, 16 Sep 2015 09:00am EDT 

AbbVie Inc:Announces plans to proceed to phase 3 evaluation of elagolix in patients with uterine fibroids.Says results from six-month, phase 2b safety and efficacy trial show elagolix met composite primary efficacy endpoint.Says phase 3 program is targeted to begin the first quarter of 2016.  Full Article

AbbVie Announces Submission of a Supplemental New Drug Application for IMBRUVICA (ibrutinib) for Treatment-Naive Chronic Lymphocytic Leukemia
Monday, 14 Sep 2015 08:30am EDT 

AbbVie Inc:Announces that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based on the randomized, multi-center, open-label Phase III RESONATETM-2 (PCYC-1115) trial.Says assessing the use of IMBRUVICA (ibrutinib) versus chlorambucil in treatment-naive chronic lymphocytic leukemia (CLL) patients aged 65 years or older.Says IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc.  Full Article

AbbVie Inc declares quarterly dividend
Friday, 11 Sep 2015 01:45pm EDT 

AbbVie Inc:Declares quarterly cash dividend of $0.51 per share.Payable Nov. 14, to stockholders of record at the close of business on Oct. 15.  Full Article

AbbVie Inc's Humira drug receives U.S. FDA approval for moderate to severe Hidradenitis Suppurativa
Thursday, 10 Sep 2015 03:43pm EDT 

AbbVie Inc:Abbvie's humira® (adalimumab) receives first and only U.S. food and drug administration approval for moderate to severe hidradenitis suppurativa.Orphan drug designation provides humira potential to be granted 7 years of market exclusivity for the treatment of moderate to severe hs.  Full Article

United Therapeutics Corporation agrees to sell priority review voucher to AbbVie
Wednesday, 19 Aug 2015 06:00am EDT 

United Therapeutics Corporation:Announces that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PPRV) to a subsidiary of AbbVie Inc.Says upon closing of the transaction, United Therapeutics will receive $350 million in cash in exchange for the PPRV.  Full Article

AbbVie Inc says Phase 2 study of venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia with 17P deletion meets primary endpoint
Wednesday, 12 Aug 2015 08:30am EDT 

AbbVie Inc:Sasy Phase 2 study of venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia with 17P deletion meets primary endpoint.Says AbbVie plans to submit regulatory applications for venetoclax to the U.S. FDA and ema before end of 2015.  Full Article

European Commission approves AbbVie Inc's HUMIRA
Thursday, 30 Jul 2015 02:00am EDT 

AbbVie Inc:Says that HUMIRA is approved for the treatment of active moderate to severe hidradenitis suppurativa in adults with an inadequate response to conventional systemic HS treatment.HUMIRA is now the first and only medication approved for HS in the European Union.  Full Article

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AbbVie forges deeper into cancer, as clock ticks for Humira

AbbVie Inc placed another big bet on new cancer drugs on Thursday with a $5.8 billion acquisition that could lessen its dependence on arthritis treatment Humira, the world's top selling drug.

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