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AbbVie’s Skyrizi becomes first drug to win FDA nod for Crohn’s disease

AbbVie (NYSE:ABBV) has announced that FDA has approved Skyrizi (risankizumab-rzaa) as the first interleukin-23 (IL-23) inhibitor to treat adults with moderately to severely active Crohn’s disease (CD).

Skyrizi is also FDA-approved as a treatment for moderate to severe plaque psoriasis and active psoriatic arthritis.

IL-23 inhibitors have surged in popularity recently, given their ability to treat diseases such as plaque psoriasis.

Janssen’s Stelara (ustekinumab), which inhibits both IL-12 and IL-23, has racked up the most indications. It is now FDA-approved for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Stelara was first FDA-approved in 2009.

Skyrizi is a newer drug, winning FDA approval for plaque psoriasis in 2019.

A 2019 analysis found that Skyrizi had higher efficacy than placebo and Stelara in treating moderate-to-severe chronic plaque psoriasis.

AbbVie touts positive cariprazine data in major depressive disorder

The schizophrenia and bipolar drug cariprazine (Vraylar) fared well as an adjunctive therapy in the Phase 3 3111-301-001 study involving patients with major depressive disorder (MDD).

AbbVie (NYSE:ABBV) is aiming to win a new FDA indication for the drug as an adjunctive treatment of MDD by the end of the year.

According to MedPage Today, 44% of patients in the 1.5-mg arm had at least a 50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score by week 2 of treatment.

The company did not divulge significant data in a news release, stating that patients receiving a 1.5mg/day dose of the drug met the primary endpoint of statistically significant improvement based on the MADRS at week six compared to placebo. Patients receiving 3.0 mg/day per day had an improved MADRS total score, but the results were not statistically significant.

Patients in the 1.5 mg group also saw improvements in their scores on the Hamilton Depression Rating Sc…

AbbVie’s Rinvoq supports clinical remission in Phase 3 Crohn’s disease study

AbbVie (NYSE:ABBV) has revealed positive topline results from the U-ENDURE Phase 3 study investigating 15- and 30-mg doses of Rinvoq (upadacitinib) in adults with moderate to severe Crohn’s disease.

Recipients who received either dose met the co-primary endpoints of endoscopic response and clinical remission, AbbVie announced. More than one-third (36%) of participants who received 15 mg of upadacitinib achieved clinical remission at week 52. A total of 46% of those receiving the 30-mg dose achieved the same benchmark, compared with 14% of placebo recipients.

Subjects also achieved the secondary endpoint of endoscopic remission at 52 weeks compared to placebo.

Study participants were poor candidates for conventional or biologic therapy.

The study defined clinical remission using the Crohn’s Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP).

Rinvoq first won FDA approval in 2019 for rheumatoid ar…

Teva and Allergan reportedly agree to pay $5B billion to settle opioid allegations

[Prescription pill bottle image courtesy of Pexels]

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and AbbVie unit Allergan Plc (NYSE:ABBV) could pay more than $5 billion in total to settle some 3,500 opioid lawsuits, according to Bloomberg. While the two companies are willing to settle the suits in the consolidated case, the deal has not been finalized.

The consolidated case is titled In Re National Prescription Opioid Litigation, 17-MD-2804, U.S. District Court, Northern District of Ohio (Cleveland).

Teva and Allergan have reportedly been in mediation for more than a year.

In 2016, Teva completed a $40.5 billion acquisition of Allergan’s generic business, including generic opioids.

In 2020, AbbVie acquired Allergan.

Earlier this year, Teva Pharmaceuticals and AbbVie reached a deal with Rhode Island for a total of $28.5 million to settle opioid-related claims.

Teva entered…

FDA approves AbbVie’s Rinvoq for active ankylosing spondylitis

AbbVie (NYSE:ABBV) has notched a new approval for the Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine.

The drug was first approved for treating rheumatoid arthritis in 2019. Indications followed for psoriatic arthritis, atopic dermatitis and ulcerative colitis.

The ankylosing spondylitis indication is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) inhibitors.

AbbVie provided data from two pivotal studies showing the drug supported The Assessment in SpondyloArthritis international Society 40% (ASAS40) benchmark to win the latest indication.

Rinvoq image courtesy of AbbVie

ASAS40 refers to an at least 40% improvement in three out of four domains related to back pain, disease activity, physical function and inflammation. The ASAS40 respons…

10 leading pharma executives you need to know

Pfizer CEO Dr. Albert Bourla [Image courtesy of Pfizer/Business Roundtable]Given the complexity of the pharmaceutical business, it can be challenging to gauge the performance of any chief executive in the space.

That said, CEOs’ annualized return over tenure as CEO over their term can hint at performance. In addition, rating sites like Glassdoor also indicate CEOs’ popularity.

Here, we parsed a range of metrics, including CEOs’ approval ratings, their ability to navigate the pandemic and their firms’ stock performance over time, to identify ten leading pharma executives.

Get the full story from our sister site, Drug Discovery & Development.

50 of 2021’s best-selling pharmaceuticals

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments.

Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for the Pfizer-BioNTech vaccine is likely to keep Pfizer as the biggest pharma firm of 2022 as well. (Look out for more insights from our annual Pharma 50 report.)

The second-best-selling drug of 2021 was AbbVie’s injectable biologic Humira, which generated $20.7 billion in sales. Next in line was Moderna’s COVID-19 vaccine, which drove $17.7 billion in revenue. Merck’s megablockbuster Keytruda rounded out the top four with $17.2 billion in revenue.

Novartis and Roche have struggled to commercialize COVID-19 therapies, although the latter has introduced a series of SARS-CoV-2 diagnostics. T…

AbbVie shares positive investigational navitoclax combination data in Phase 2 Refine trial in patients with rare blood cancer

AbbVie (NYSE:ABBV) has announced new data from a Phase 2 study of navitoclax with ruxolitinib in patients with myelofibrosis, a rare bone marrow cancer.

The data indicate that the combination therapy induces cell death, potentially leading to the reversal of bone marrow fibrosis and improving survival for patients who respond to the therapy.

The study found that 12 out of 32 patients had improvements in bone marrow fibrosis. To date, however, the study did not reach the median overall survival for the overall survival.

The company presented the results at the American Association for Cancer Research annual meeting (AACR 2022, abstract #LB108).

Navitoclax is a small-molecule-based, experimental, novel oral BCL-XL/BCL-2 inhibitor designed to activate programmed cell death (apoptosis) in cancer cells.

Overall, Navitoclax has been the subject of 39 trials to date.

North Chicago, Illinois–based AbbVie presented the results at AACR 2022 fr…

AbbVie and Gedeon Richter unveil neuropsychiatric alliance

AbbVie (NYSE:ABBV) and Gedeon Richter have formed a co-development and license agreement focused on novel dopamine receptor modulators with the potential to treat neuropsychiatric diseases.

Lake Bluff, Illinois-headquartered AbbVie and Budapest, Hungary-based Gedeon Richter have already collaborated for 15 years in central nervous system projects, including the development of cariprazine (Vraylar/Reagila), which is now authorized to treat conditions such as schizophrenia and bipolar disorder.

Richter has identified several new chemical entities to pursue with Gedeon Richter and has already performed preclinical research on them.

“In collaboration with Richter, we will continue to build on our research that seeks to provide additional insights into our understanding of cariprazine’s clinical pharmacology and explore novel chemistry to identify new dopamine receptor modulators,” said Tom Hudson, MD, senior vice president, R&D, chief s…

AbbVie shares positive Phase 3 atogepant data to prevent chronic migraine

Gepants have gained ground in recent years as a migraine treatment following the FDA’s approval of Allergan’s Ubrelvy (ubrogepant) in 2019.

Now, AbbVie (NYSE:ABBV) has announced that a Phase 3 study testing Qulipta (atogepant) met its primary endpoint of reducing mean monthly migraine days over placebo.

FDA approved atogepant as a preventive treatment of episodic migraine in adults on September 28, 2021.

The company hopes the data will convince FDA to authorize the expanded use of atogepant as a preventive treatment of chronic migraine.

AbbVie plans on filing a supplemental New Drug Application (sNDA) with the agency.

In the Phase 3 PROGRESS study, both the 60-mg once-daily and 30-mg twice daily versions of the oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met the endpoint over a 12-week treatment period.

In the study, 778 participants shared eDiary headache data. One treatment arm received the …

AbbVie settles Humira-related litigation with Alvotech

AbbVie (NYSE:ABBV) has announced that it has resolved U.S. litigation related to Humira (adalimumab) involving Alvotech Holdings (Reykjavik, Iceland).

The two companies have reached an agreement that will give Alvotech a non-exclusive license to AbbVie’s Humira-related patents in the U.S. starting July 1, 2023.

Under the terms of the agreement, Alvotech will pay royalties to AbbVie to license Humira patents.

In 2020, Alvotech announced that the FDA was reviewing a biologics license application related to a proposed Humira biosimilar known as AVT02. In September 2021, FDA announced that it had delayed its review of the biosimilar candidate.

On February 28, Alvotech announced that FDA had accepted Alvotech’s biologic licensing application (BLA) for ATV02 with new data supporting interchangeability between ATV02 and Humira.

“We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment,” said Robert We…

FDA lengths review of Skyrizi for Crohn’s

AbbVie (NYSE:ABBV) has announced that the FDA will prolong the review period for Skyrizi (risankizumab-rzaa) to treat moderate to severe Crohn’s disease in patients 16 years and older.

The agency decided to extend the Prescription Drug User Fee Act (PDUFA) action date for the indication by three months to review additional data submitted from the sponsor related in part to an on-body injector.

FDA first approved Skyrizi, an interleukin-23 subunit p19 inhibitor, for moderate to severe plaque psoriasis in adults. Then, in January, it won an indication for adults with active psoriatic arthritis.

AbbVie developed the drug in partnership with Boehringer Ingelheim.

Last year, sales of the drug were $2.939 billion internationally.

AbbVie has also filed an application with the European Medicines Agency asking for approval of Skyrizi to treat patients at least 16 years with moderate to severe Crohn’s disease.

ABBV shares ticked do…