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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.

Top Ten most popular articles on Pharmafile.com this week

This week was diverse as always in terms of news coming out of the pharma industry, but the biggest news was undoubtedly the announcement of a $63 billion mega-merger between AbbVie and Allergan.

However, the story most popular with our readers this week is the news that Takeda intends to vacate all 1,000 of its staff from its US HQ by the end of the year.

10.

AbbVie poised to acquire Allergan for $63 billion

The industry has been rocked with the announcement of another pharmaceutical mega-merger, as it emerged that AbbVie had sealed an agreement with Allergan to acquire the latter for approximately $63 billion, making it one of the biggest mergers of its kind.

The total valuation of the deal is based on the closing price on 24 June of AbbVie’s common stock of $78.45, and will take the form of a cash and stock transaction.

AbbVie's Venclyxto combo outclasses chemo in treatment-naive chronic lymphocytic leukaemia

AbbVie was one of many companies to present new data at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, focusing specifically on its B-cell lymphoma-2 (BCL-2) inhibitor Venclyxto (venetoclax) in combination with obinutuzumab in the treatment of previously untreated chronic lymphocytic leukaemia (CLL).

In the first randomised trial to investigate stopping an oral-based, chemotherapy-free combination after 12 months in the disease, it was found that the drug combo, which AbbVie is jointly developing with Roche, achieved superior rates of progressio

AbbVie terminates Phase 3 brain cancer study after Depatux-M shows no benefit

AbbVie has terminated a Phase 3 study of the efficacy of Depatux-M (depatuxizumab mafodotin) in the treatment of newly diagnosed glioblastoma (GBM) in patients whose tumours have epidermal growth factor receptor (EGFR) amplification, after it was identified in an interim analysis that the therapy presented no survival benefit to patients.

FDA greenlights Roche and AbbVie's Venclexta for chronic lymphocytic leukaemia

Venclexta (venetoclax), the oral B-cell lymphoma-2 (BCL-2) inhibitor co-developed by AbbVie and Roche, has been approved by the FDA in combination with Gazyva (obinutuzumab) for the treatment of chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have not received prior treatment.

The US agency reached the decision in just two months through the Breakthrough Therapy pathway, based on the data which indicated that the combo “demonstrated superior progression-free-survival (PFS)”, as assessed by an independent review committee.

FDA approves AbbVie's Mavyret for children with Hepatitis C (HCV)

The FDA has approved AbbVie’s Mavyret tables (glecaprevir/pibrentasvir) as a treatment for hepatitis C (HCV) in children aged 12 to 17 years old.

AbbVie’s two drug combo tablets have been approved as a treatment for all six genotypes of HCV in children. The combination of glecaprevir and pibrentasvir was approved for adults in 2017.

AbbVie's Skyrizi snatches up FDA approval in moderate to severe plaque psoriasis

AbbVie has revealed that its interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab-rzaa) has received marketing authorisation in the US from the FDA in the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

According to the company, Skyrizi produced “high rates of durable skin clearance” in two Phase 3 clinical trials. The approval was based on data which showed that, after 16 weeks, 75% of patients achieved a Psoriasis Area and Severity Index (PASI) score of 90, compared to 5% and 2% of placebo patients.

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