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AbbVie

UK High Court rules against AbbVie’s Humira patents

The UK High Court has ruled that two of AbbVie patents, related to dosing regimens for rheumatoid arthritis, psoriasis and psoriatic, were invalid. The case was brought by claimants Samsung Bioepis, Biogen and Fujifilm Kyowa Kirin Biologics, represented by Gowling WLG, as each tries to bring their own Humira biosimilar to the European market.

NICE rejects AbbVie’s leukaemia drug

NICE has rejected AbbVie Venclyxto (venetoclax) for the treatment of chronic lymphocytic leukmaemia, on various grounds but primarily focusing upon the evidence base for the drug. Pricing was also an issue for the drug, exceeding the £30,000 per QALY limit.

Major pharma firms join Liverpool Uni in £14m pharmacovigilance project

The UK’s University of Liverpool is to launch a £14 million pharmacovigilance project focused on using new modelling approaches to facilitate better understanding of adverse drug reactions (ADRs), with AbbVie as project leader.

Amgen drug pair become first Humira biosimilars to win EU approval

Good news for Amgen as its two biosimilar versions of AbbVie’s blockbuster rheumatoid arthritis (RA) drug Humira (adalimumab) have been awarded recommendation for approval by the European Medicines Agency (EMA) for the treatment of moderate to severe RA in patients who have not responded to methotrexate or have not been previously treated with it.

NICE approves Imbruvica for second-line leukaemia treatment

NICE has issued its Technology Appraisal Guidance (TAG) that has recommend Imbruvica (ibrutinib) for the treatment of chronic lymphocytic leukaemia (CLL) in adult patients. The treatment will be used in those patients who have been treated with one prior therapy or for those whom chemotherapy alongside immunotherapy is not possible.

EMA Accelerated Assessment for AbbVie's hepatitis C regimen

AbbVie has announced that its investigational, pan-genotypic regimen of Glecaprevir/Pibrentasvir has been awarded Accelerated Assessment by the European Medicines Agency (EMA) for the treatment of all major chronic hepatitis C virus (HCV) genotypes.

The combination treatment promises to provide an additional treatment option for those suffering from compensated cirrhosis, and also a shorter duration of treatment for genotype 1-6 patients without cirrhosis, which accounts for the majority of HCV sufferers.

European thumbs up for Abbvie leukaemia drug

Abbvie has confirmed its Venclyxto (venetoclax) has been granted marketing authorisation by the European Commission (EC) as a monotherapy for the treatment of chronic lymphocytic leukaemia (CLL) in adult patients.

Janssen reveals positive results from longest follow-up of Imbruvica

Janssen used the 5th Annual American Society of Hematoly Meeting and Exposition to reveal that a five-year study of Imbruvica (ibrutinib) had demonstrated an overall response rate of 89% in patients suffering from chronic lymphocytic leukaemia (CLL). The results from the trial also saw 29% of patients have a complete response to first-line treatment.

Humira biosimilar proves efficacy in Phase 3 trial

US-based biotechnology firm Momenta Pharmaceuticals has announced that its biosimilar version of Abbvie’s autoimmune drug Humira (adalimumab) – currently the world’s best-selling medicine – met its primary endpoint in a Phase 3 psoriasis trial.

The study found that, in moderate-to-severe chronic plaque psoriasis sufferers treated for 48 weeks with M923 alone or alternating with Humira, there was an equal number of patients who achieved a psoriasis severity index reduction of 75% between M923 and its originator drug, meeting the trial’s main objective.

AbbVie investigational hep C drug boasts 97.5% response rate

AbbVie released details on their latest trials for their investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530). In an eight week trial of chronic HCV infected patients without cirrhosis and who are new to treatment, 97.5% were found to have a sustained virologic response at 12 weeks post treatment.

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