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AbbVie

AbbVie's Rinvoq smashes Phase 3 efficacy targets in atopic dermatits

AbbVie has lifted the curtain on data from the second Phase 3 trial investigating the efficacy of Rinvoq (upadacitinib) monotherapy in the treatment of moderate to severe atopic dermatitis in adults and adolescent patients eligible for systemic therapy, after the drug nailed its primary and secondary endpoints.

The drug was aiming to elicit a 75% improvement from baseline in patients on the Eczema Area Severity Index (EASI 75), as well as a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) after 16 weeks of treatmen

FDA rejects Allergan's Abicipar pegol for neovascular age-related macular degeneration over benefit/risk concerns

The FDA has moved to reject Allergan’s vascular endothelial growth factor (VEGF) factor A inhibitor, Abicipar pegol, as treatment for the eye condition known as neovascular age-related macular degeneration (nAMD).

The drug application was supported by data from two trials which showed the non-inferiority of Abicipar pegol to Genentech’s Lucentis (ranibizumab) in treatment-naïve (nAMD), with six or eight injections of the former proving as effective as 13 doses of the latter after 52 weeks.

AbbVie’s Venclexta plus azacitidine shows improved survival and remissions rates in leukaemia patients

U.S. Air Force photo by Heide Couch

AbbVie have announced positive results from its latest Phase 3 clinical trial where Venclexta plus azacitidine improved survival and remission rates in treatment-naïve acute myeloid leukaemia patients (AML).

AbbVie and Genmab sign drug development and commercialisation deal worth up to $4bn

AbbVie has joined forces with Genmab to develop and commercialise three of the latter’s early-stage Genmab drug products – epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4 – and partner up on the discovery of up to four future therapies for cancer, in a deal worth almost $4 billion.

Commercial responsibilities for the first of these products will be shared by both companies in the US and Japan, with AbbVie handling marketing duties in the rest of the world.

$63bn Allergan/AbbVie merger review could be delayed by coronavirus

The $63 billion merger of major pharma players AbbVie and Allergan could be facing hurdles on the road to regulatory sign-off as the ongoing COVID-19 coronavirus outbreak continues to put the squeeze on global operations.

The issue became known when both the Federal Trade Commission (FTC) and the antitrust division of the US Department of Justice (DOJ) both reported that their review process has been impacted by the outbreak, and may result in them seeking extensions to give them more time to look over the proposed deal.

Venclyxto combo scores European approval for previously untreated chronic lymphocytic leukaemia

Image Credit: Mary Ann Thompson

The European Commission has moved to authorise AbbVie and Roche’s B-cell lymphoma-2 (BCL-2) inhibitor Venclyxto (venetoclax) when used in combination with obinutuzumab for the treatment of chronic lymphocytic leukaemia (CLL) in previously untreated adult patients.

Phase 3 data supplied in support of the application showed that the drug combo demonstrated superior progression-free survival (PFS) compared to a regimen containing standard-of-care chemotherapy chlorambucil plus obinutuzumab; 36-month PFS estimates stood at 81.9% compared to 49.5% with chlorambucil plus obinutuzumab.

AbbVie's Rinvoq hits target in psoriatic arthritis sub-population at Phase 3

AbbVie has unveiled new Phase 3 data on its selective and reversible JAK inhibitor Rinvoq (upadacitinib) in the treatment of active psoriatic arthritis in adults who have responded inadequately or are intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs).

The results revealed that 71% of patients receiving 15mg Rinvoq and 79% receiving 30mg achieved an ACR20 response after 12 weeks of treatment compared to 36% with placebo, meeting the trial’s primary endpoint.

AbbVie's Venclyxto pins down CHMP approval for treatment-naive chronic lymphocytic leukaemia

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has awarded recommendation to AbbVie’s Venclyxto (venetoclax), it has emerged, in the treatment of previously untreated chronic lymphocytic leukaemia (CLL) when combined with obinutuzumab.

Phase 3 data submitted in support of the application showed that Venclyxto displayed “superior” benefit in progression-free survival compared to the standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil, meeting the study’s primary endpoint.

AbbVie's Skyrizi outpaces Novartis' Cosentyx in plaque psoriasis skin clearance

AbbVie has made it known that Skyrizi (risankizumab) outpaced Novartis’ Cosentyx (secukinumab) at Phase 3 in the treatment of plaque psoriasis, hitting both its primary and all ranked secondary endpoints.

The data revealed “significantly higher” skin clearance rates for Skyrizi compared to Cosentyx, with 87% experiencing an improvement of at least 90% from baseline at 52 weeks of treatment, according to the Psoriasis Area and Severity Index (PASI), compared to just 57% with the latter.

AbbVie granted EU marketing authorisation for new arthritis drug

AbbVie have announced that the European Commission (EC) have granted marketing authorisation for RINVOQ (upadacitnib). It’s a daily selective reversible JAK inhibitor for the treatment of adults with moderate to severe rheumatoid arthritis, who are intolerant of other similar drugs.

It may be used as a monotherapy or in combination with methotrexate.

The EC authorisation of RINVOQ is based on data from a Phase 3 trial which saw 4,400 patients participate.

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