AbbVie

AbbVie (NYSE:ABBV) has submitted a supplemental New Drug Application (sNDA) to the FDA to support the use of atogepant (Qulipta) as a preventive treatment of both episodic and chronic migraine. FDA approved the drug in September 2021 as a preventive treatment of episodic migraine in adults. In March 2022, AbbVie announced that the Phase 3…

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…

The schizophrenia and bipolar drug cariprazine (Vraylar) fared well as an adjunctive therapy in a 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%…

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…

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…

Given the complexity of the pharmaceutical business and the generally slow pace of new drug development, it can be challenging to identify leading pharma executives. Compensation is not necessarily an accurate barometer of success. That said, CEOs’ annualized return over tenure as CEO over their term can hint at performance. In addition, rating sites like Glassdoor…

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…

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments. This roundup of best-selling pharmaceuticals in 2021 highlighted a banner year for the industry. Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the…

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…

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…

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 (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…

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT). Two companies in pharma and another in medtech, however, made the cut. Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator. Roche was included for the 11th consecutive year…

AbbVie (NYSE: ABBV) has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar) for major depressive disorder (MDD). FDA first approved cariprazine for schizophrenia and bipolar disorder in 2015. Current indications of the drug cover the acute treatment of manic or mixed episodes related to bipolar I disorder and depressive episodes associated with bipolar…

Viatris (NSDQ:VTRS) has received FDA approval for the first generic of Restasis (cyclosporine ophthalmic emulsion) eye drops. FDA first approved the drug, which was developed by Allergan, in 2003. Now marketed by AbbVie (NYSE:ABBV), Restasis sales are on the order of $1.2 billion annually. AbbVie recently noted in its projections for 2022 that it expected…

FDA first approved AbbVie’s (NYSE:ABBV) interleukin-23 inhibitor Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis in 2019. Now, the agency has extended the approval to include adults with active psoriatic arthritis (PsA), which affects almost one out of three people with psoriasis. To win the new indication, AbbVie provided data from the KEEPsAKE-1 and KEEPsAKE-2 pivotal studies.…

FDA has approved Rinvoq (upadacitinib) from AbbVie (NYSE:ABBV) to treat moderate to severe atopic dermatitis in individuals at least 12 years old. AbbVie anticipates 2025 risk-adjusted sales for Rinvoq to top $7.5 billion. The most common type of eczema, atopic dermatitis, can be managed with various therapies, including corticosteroids, topical calcineurin inhibitors and immunosuppressants. Nevertheless, the…

AbbVie (NYSE:ABBV) has submitted applications asking for approval of upadacitinib (Rinvoq) from the FDA and the European Medicines Agency (EMA) to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA). If approved, Rinvoq would be indicated for nr-axSpA patients with objective signs of inflammation with an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). The Janus kinase…

AbbVie (NYSE:ABBV) subsidiary Allergan has received FDA approval for Vuity (pilocarpine HCl ophthalmic solution), a novel eye drop for treating presbyopia. This common age-related condition leads millions of middle-aged people to acquire reading glasses. Vuity is a once-daily prescription eye drop. Presbyopia, or age-related blurry near vision, can be diagnosed through a basic eye exam…

AbbVie (NYSE:ABBV) has released positive top-line results from U-EXCEED, which showed that Rinvoq (upadacitinib) hit both primary endpoints of clinical remission and endoscopic response at week 12 of a Phase 3 induction study focused on patients with Crohn’s disease. Upadacitinib is a selective and reversible JAK inhibitor first FDA approved in 2019 for treating adults with…

AbbVie (NYSE: ABBV) has extended an agreement with the University of Chicago related to collaborative preclinical oncology research. The North Chicago, Illinois–based company and the university are working together on research involving biomarkers and therapeutic applications related to existing AbbVie programs. In the past, the organizations have also explored new drug delivery methods to improve…

Regenxbio (NSDQ:RGNX) has closed a license agreement with AbbVie (NYSE:ABBV) to develop RGX-314, a vascular endothelial growth factor inhibitor. The drug has been the focus of Phase 2 and Phase 3 trials exploring its potential in wet age-related macular degeneration (AMD) and diabetic retinopathy. AbbVie will make an upfront payment to Regenxbio of $370 million…

Abbvie’s (NYSE:ABBV) JAK inhibitor Rinvoq (upadacitinib) beat out placebo at week 24 in posthoc analyses of two Phase 3 studies focused on people with active psoriatic arthritis. In particular, the drug led to a superior clinical response related to axial involvement, which occurs in a substantial portion of people with psoriatic arthritis. Sharing the data…

AbbVie (NYSE:ABBV) announced that the interleukin-23 antagonist Skyrizi (risankizumab) had received backing from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat active psoriatic arthritis. The committee recommended the drug for adults with active psoriatic arthritis who have had an inadequate response or who have been intolerant to one…

AbbVie (NYSE:ABBV) has announced positive top-line results in a Phase 3 trial focusing on patients with active ankylosing spondylitis (AS), an inflammatory disease that can eventually lead to fused vertebrae. The first of two studies, the SELECT-AXIS 2 study examined a daily 15-mg dose of Rinvoq (upadacitinib) in AS patients who had an inadequate response…