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AbbVie announces positive results from head-to-head study of Skyrizi in Crohn’s disease

AbbVie has shared detailed results from a head-to-head study comparing its IL-23 inhibitor Skyrizi (risankizumab) to Johnson & Johnson’s Stelara (ustekinumab) in Crohn’s disease. The late-stage SEQUENCE study has been evaluating the drugs, both given as a subcutaneous injection every eight weeks after a lead-in period of intravenous infusions, in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. Despite the availability of a range of treatments, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery. The results from SEQUENCE, which were presented at the United European Gastroenterology Week, showed that Skyrizi was superior to J&J’s IL-12 and IL-23 inhibitor at achieving endoscopic remission after 48 weeks of treatment, with 32% and ...
- Source: drugdu
- 111
- October 19, 2023
AbbVie Completes Acquisition of Mitokinin

Addition strengthens neuroscience pipeline, company says. Image Credit: Adobe Stock Images/chinnarach AbbVie announced that it has exercised its exclusive right and completed the acquisition of Mitokinin, a biotech company focused on developing treatments for Parkinson’s disease. Under terms of the acquisition, AbbVie will pay Mitokinin shareholders $110 million at closing for the acquisition of Mitokinin, with shareholders remaining eligible for potential additional payments of up to $545 million upon the achievement of certain development and commercial milestones related to Pink1, Mitokinin’s lead compound designed to address mitochondrial dysfunction that is believed to be a major contributing factor to Parkinson’s disease pathogenesis and progression. “Parkinson’s disease continues to be a major unmet medical need, impacting patients, caregivers and society. With this acquisition, we are excited to grow our neuroscience portfolio and explore a potential new treatment option for PD,” said Jonathon Sedgwick, PhD, VP, global head of discovery research, AbbVie. “While ...
- Source: drugdu
- 142
- October 9, 2023
AbbVie Ends I-Mab Deal for CD47 Antibody Compounds, Products

By Tristan Manalac Pictured: AbbVie headquarters in California/iStock, Michael Vi AbbVie has terminated its license and collaboration agreement with I-Mab, the Maryland- and Shanghai-based biotech announced in an SEC filing posted Friday. As a result, I-Mab will regain the global rights to develop and commercialize all CD47 compounds covered by the deal, including the monoclonal antibody lemzoparlimab. The termination will take effect on Nov. 20, 2023 and will not affect the $200 million in upfront and milestone payments that I-Mab had already received from AbbVie. According to I-Mab’s SEC document, AbbVie is pulling away from the partnership as a “strategic decision,” though a prior program discontinuation also factored into its decision. AbbVie and I-Mab first entered into their global agreement in September 2020. For an upfront payment of $180 million and the promise of up to $1.74 billion in success-based milestones, AbbVie earned exclusive rights—outside of the greater China area—to ...
- Source: drugdu
- 177
- September 27, 2023
AbbVie Passes on License Option for Harpoon’s TriTAC Multiple Myeloma Program

By Tristan Manalac Pictured: AbbVie corporate office in California/iStock, vzphotos AbbVie will not exercise its exclusive licensing option for Harpoon Therapeutics’ HPN217 program, being developed for the treatment of multiple myeloma, the immuno-oncology biotech announced Wednesday. Harpoon will retain exclusive ownership over HPN217, for which it is running a Phase I clinical trial. The company will complete the study and plans to advance the candidate through its next phases of development. Despite AbbVie’s decision, Harpoon CEO Julie Eastland said in a statement that the biotech remains “confident in HPN217’s potential” to offer multiple myeloma patients “a differentiated treated option.” The company will share interim results from the candidate’s Phase I study at the upcoming International Myeloma Society (IMS) Annual Meeting, scheduled for Sept. 28, Eastland said. Developed using Harpoon’s proprietary TriTAC technology, HPN217 targets the B-cell maturation antigen, a protein highly and specifically expressed on myeloma cells. TriTAC, which stands ...
- Source: drugdu
- 109
- September 16, 2023
AbbVie shares positive results from head-to-head study of Skyrizi in Crohn’s disease

AbbVie has shared positive top-line results from a head-to-head study of its interleukin-23 inhibitor Skyrizi (risankizumab) in Crohn’s disease. The late-stage study, SEQUENCE, has been evaluating the drug against Johnson & Johnson’s Stelara (ustekinumab) in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Skyrizi was shown to match Stelara in terms of clinical remission at week 24, with remission rates of 59% in the Skyrizi group and 40% in the Stelara cohort. On the second primary endpoint of endoscopic remission at week 48, Skyrizi demonstrated superiority to Stelara, with remission rates of 32% and 16%, respectively. All secondary endpoints achieved statistical significance for superiority versus Stelara, AbbVie said, and safety results were consistent with the overall safety profile of Skyrizi. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. It is ...
- Source: drugdu
- 149
- September 15, 2023
AbbVie’s Skyrizi Outperforms J&J’s Stelara in Late-Stage Crohn’s Disease Trial

By Tristan Manalac Pictured: AbbVie headquarters in California/iStock, Michael Vi Topline data from the Phase III SEQUENCE trial showed that AbbVie’s Skyrizi (risankizumab) matched, and could potentially even outpace, Johnson & Johnson’s Stelara (ustekinumab) in patients with Crohn’s disease. SEQUENCE was designed to establish the non-inferiority of Skyrizi compared to Stelara in terms of clinical remission. AbbVie’s IL-23 inhibitor not only met this bar, but also demonstrated signals of superiority: 59% of Skyrizi-treated patients achieved remission, as opposed to only 40% among Stelara comparators. Remission, the study’s primary endpoint, was defined as scores lower than 150 in the Crohn’s Disease Activity Index, measured at week 24. “These head-to-head data reinforce SKYRIZI is an effective treatment option for patients living with Crohn’s disease,” Roopal Thakkar, AbbVie’s chief medical officer and senior vice president of development and regulatory affairs, said in a statement. SEQUENCE’s results also highlight the role Skyrizi can play ...
- Source: drugdu
- 108
- September 15, 2023
AbbVie achieves win for migraine prevention drug Aquipta in Europe

The European Commission has approved AbbVie’s Aquipta as migraine prophylaxis for adult patients, making it the first daily oral treatment of its class to be approved in the EU for the prevention of both chronic and episodic migraines. Several calcitonin gene-related peptide (CGRP) antibodies are administered subcutaneously or via intravenous infusions. But there is a preference among patients for oral therapies, says Dawn Carlson, vice president, Neuroscience Development at AbbVie, in an interview with Pharmaceutical Technology. Lundbeck’s CGRP antibody Vyepti (eptinezumab), is administered through intravenous infusions, while Amgen’s Aimovig (erenumab) is injected subcutaneously. The approval of Aquipta is based on the results of the two Phase III studies—ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which both met their primary endpoint of a statistically significant reduction in mean monthly migraine days versus placebo, per the 17 August announcement. In the PROGRESS trial, patients in the 60mg Aquipta cohort reported a 6.8-day reduction in ...
- Source: drugdu
- 120
- August 22, 2023
Sandoz launches high-concentration biosimilar of AbbVie’s Humira in the US

Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab). Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs. Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg ...
- Source: drugdu
- 116
- July 7, 2023
AbbVie, Genmab’s Epkinly shows promise in follicular lymphoma. Will FDA get on board?

Merely a month into an FDA approval, AbbVie and Genmab’s bispecific drug Epkinly has chalked up a positive readout that might enable an expansion in blood cancer, although the exact regulatory path remains unclear. Epkinly significantly beat back tumors in 82% of patients with relapsed or refractory follicular lymphoma in a phase 1/2 trial, the companies said Tuesday. The patients had received a minimum two—and a median three—prior lines of systemic therapy. The median duration of response hasn’t been reached in Epkinly’s study, and investigators are still following patients. The companies also didn’t disclose the complete response rate. Full results from the study will be shared at a future medical meeting. Epkinly snagged an FDA approval for previously treated diffuse large B-cell lymphoma (DLCLC) in May, and AbbVie and Genmab said they will talk to regulators about next steps in FL, an indolent form of lymphoma. If approved in the ...
- Source: drugdu
- 107
- June 30, 2023
AbbVie’s migraine medication Qulipta gets positive CHMP opinion

AbbVie announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its migraine medication Qulipta (atogepant). Once the CHMP has issued a positive opinion, the EMA will send a recommendation to the European Commission (EC) to approve it. While not a guarantee, a positive CHMP opinion is generally a good indication that a drug is likely to be approved. In a June 2023 statement, AbbVie claims that full approval from the European Commission (EC) would position Qulipta as the only daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment for episodic and chronic migraines available in the EU. Qulipta is approved for use in the US. In 2021, it managed to secure FDA approval to treat episodic migraine, receiving further approval this year to also treat chronic migraine. The positive opinion is based on Phase III trial results submitted ...
- Source: drugdu
- 103
- June 25, 2023

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