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AbbVie

International revenue for world's best-selling drug Humira falls 33.5% in the face of biosimilar competition

With the release of its Q3 financial results, AbbVie confirmed that international revenues for its blockbuster therapy Humira (adalimumab) – the best-selling drug in the world – had taken a considerable hit in the face of biosimilar competition, falling 33.5% on a reported basis.

Total global revenues for the drug stood at $4.936 billion, a much stronger showing compared to the $1.049 billion generated internationally, and only fell by 3.7% overall.

AbbVie's Rinvoq impresses at Phase 3 in active psoriatic arthritis sub-population

AbbVie has unveiled new Phase 3 data on two doses of its JAK inhibitor Rinvoq (upadacitinib), showing that the therapy met its primary endpoint in the treatment of  active psoriatic arthritis in adult patients who have responded inadequately to one or more biologic disease modifying anti-rheumatic drugs (bDMARDs).

The data revealed that both 15mg and 30mg formulations generated an ACR20 response on the American College of Rheumatology’s measure of the disease in 57% and 64% of patients respectively, following 12 weeks of treatment compared to 24% with placebo.

Takeda's Entyvio outperforms AbbVie's Humira in moderate-to-severe ulcerative colitis

Takeda has released strong new data for Entyvio (vedolizumab), showing that the gut-selective biologic outperformed AbbVie’s blockbuster anti-tumour necrosis factor-alpha (TNFα) biologic Humira (adalimumab) in the treatment of moderately to severely active ulcerative colitis (UC).

Data showed that 34.2% of anti-TNFα-naïve patients treated with Entyvio saw clinical remission after 52 weeks of treatment compared to 24.3% with Humira, meeting the trial’s primary endpoint, while these rates stood at 20.3% in anti-TNFα-experienced patients compared to 16%.

AbbVie's Mavyret scores FDA label expansion to shorten treatment duration for hepatitis C patients

The FDA has chosen to expand the existing label for AbbVie’s Mavyret (glecaprevir/pibrentasvir), it has been revealed, to include the treatment of previously untreated patients over the age of 12 who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis.

The approval will see the duration of treatment with the drug shortened from 12 to eight weeks.

Ayala hires AbbVie’s Gary Gordon as new CMO

Published on: 10/09/19

AbbVie’s former Vice President of Oncology has moved to Ayala Pharmaceuticals to work as its new Chief Medical Officer (CMO). 

Israel-based startup Ayala Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing targeted cancer therapies for people living with genetically defined cancers – it is currently working on the development of its pan-Notch inhibitor AL101, currently in Phase 2 in adenoid cystic carcinoma (ACC).

AbbVie shuts down Rova-T development in first-line advanced small-cell lung cancer following another trial failure

AbbVie has announced its intention to terminate development of Rova-T (rovalpituzumab tesirine) in the first-line maintenance of advanced small-cell lung cancer (SCLC).

The decision was reached on the recommendation of an independent data monitoring committee, following the failure of the drug to show survival benefit compared to placebo following platinum-based chemotherapy during a pre-planned interim analysis. Despite this failure, it was noted that the therapy’s safety profile was consistent with previous data.

FDA warns three Hepatitis C drugs may worsen liver function in some rare cases

The FDA has warned that three Hepatitis C (HCV) drugs made by AbbVie, Gilead and MSD are worsening liver function and causing liver failure in some patients.

The US regulator said it has identified 63 cases in which HCV drugs Mavyret, Zepatier, and Vosevi were worsening liver function in patients with symptoms of moderate-to-severe liver impairment and other serious liver problems.

NHS patients to receive AbbVie's Skyrizi for plaque psoriasis following NICE recommendation

AbbVie’s Skyrizi (risankizumab) has been awarded a positive recommendation from UK drug watchdog NICE, meaning that the IL-23 inhibitor will now be made available to eligible patients across England and Wales for the treatment of plaque psoriasis in those who have failed conventional systemic therapies, the company has announced.

The drug, which is jointly developed along with Boehringer Ingelheim, navigated the organisation’s Fast Track pathway; the institute's decision will now be implemented within 30 days as opposed to the traditional 90.

AbbVie scoops up FDA approval for Rinvoq in moderately to severely active rheumatoid arthritis

The FDA has awarded marketing authorisation to AbbVie’s Rinvoq (upadacitinib) for the treatment of moderately to severely active rheumatoid arthritis, it has emerged, in adult patients who have shown inadequate response or intolerance to methotrexate (MTX).

Data submitted in support of the application was drawn from one of the largest Phase 3 trial programmes in this indication, encompassing around 4,400 patients across five studies; Rinvoq met all primary and ranked secondary endpoints across these studies.

Humira biosimilar from Samsung Bioepis and MSD wins marketing authorisation in the US

It’s another victory for MSD as the US drugmaker announced that its biosimilar version of AbbVie’s Humira – the world’s best-selling medicine – has received marketing authorisation from the FDA.

The approval for the drug, known as Hadlima and developed by Samsung Bioepis, covers the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, just like its reference product.

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