AbbVie Inc. reports pharmaceutical developments across immunology, neuroscience, oncology and Allergan Aesthetics. Recurring updates include financial results by product portfolio, clinical and real-world data for therapies such as SKYRIZI and RINVOQ, FDA regulatory submissions and response letters, and medical-conference presentations in inflammatory bowel disease and other immune-mediated conditions.
Company news also covers pipeline spending, acquired in-process research and development, manufacturing capacity for medicines in core therapeutic areas, and investor conference appearances. AbbVie’s product references commonly include SKYRIZI, RINVOQ, Botox Therapeutic, Vraylar, Ubrelvy, Qulipta, Venclexta, Imbruvica and Elahere.
AbbVie announced that LASTACAFT (alcaftadine ophthalmic solution 0.25%) is now available over-the-counter, previously requiring a prescription. This antihistamine eye drop provides relief from itchy allergy eyes caused by seasonal and year-round allergens, working within three minutes and lasting for 16 hours. With an estimated 40% of Americans affected by ocular allergies, this move expands AbbVie's retail eye drop portfolio, alongside the REFRESH product line. LASTACAFT is available in a 5 mL bottle with a 60-day supply or a twin pack for 120 days, enhancing accessibility for allergy sufferers.
AbbVie and Scripps Research have announced a global collaboration to develop new antiviral treatments for COVID-19, aimed at addressing the evolving needs due to new virus variants. The partnership leverages Scripps' expertise and resources, with initial funding support from the Bill & Melinda Gates Foundation. This initiative represents AbbVie's commitment to enhancing access to innovative oral antiviral treatments. The collaboration's success hinges on regulatory approvals and customary closing conditions.
AbbVie and Gedeon Richter have announced a new collaboration to develop novel dopamine receptor modulators targeting neuropsychiatric diseases. This partnership, extending their 15-year relationship, involves shared R&D financing and includes preclinical efforts for new chemical entities. AbbVie will maintain global commercialization rights, with Richter receiving an upfront payment and potential milestone payments. The deal is expected to close in Q2 2022, pending regulatory approvals. This collaboration aims to enhance treatment options for patients with complex neuropsychiatric conditions.
AbbVie announced that the Phase 3 PROGRESS trial for atogepant (QULIPTA™) met its primary endpoint, showing significant reductions in mean monthly migraine days in adults compared to placebo. Patients receiving 60 mg once daily or 30 mg twice daily reported decreases of 6.88 and 7.46 days, respectively. The trial included 778 patients and demonstrated significant improvements across all secondary endpoints. AbbVie plans to submit a supplemental New Drug Application to expand atogepant's use for chronic migraine prevention in the U.S. Safety profiles were consistent with prior studies, with the most common side effects being constipation and nausea.
AbbVie has successfully resolved all patent litigation in the U.S. regarding its HUMIRA (adalimumab) product with Alvotech. Starting July 1, 2023, AbbVie will grant Alvotech a non-exclusive license for HUMIRA-related patents, with Alvotech agreeing to pay royalties. No payments will be made from AbbVie to Alvotech, and the litigation has been dismissed, affirming the validity of AbbVie's patents. This resolution marks a significant milestone in AbbVie's litigation strategy concerning HUMIRA.
Genmab A/S (NASDAQ: GMAB) announced that the FDA has granted orphan-drug designation to epcoritamab (DuoBody®-CD3xCD20) for treating follicular lymphoma (FL). This designation aids the development of treatments for rare diseases affecting fewer than 200,000 people annually. FL is the second most common form of non-Hodgkin’s lymphoma, impacting approximately 2.7 per 100,000 people in the U.S. Epcoritamab is currently in multiple clinical trials, providing hope for patients who are refractory to conventional therapies.
AbbVie (NYSE: ABBV) will participate in the Cowen 42nd Annual Health Care Conference on March 8, 2021, presenting virtually at 11:50 a.m. Central Time. Key executives include Robert A. Michael, Michael E. Severino, M.D., and Jeffrey R. Stewart. A live audio webcast will be available on AbbVie's Investor Relations website, with an archived edition accessible later that day. AbbVie focuses on innovative medicines across various therapeutic areas, including immunology, oncology, and neuroscience, aimed at addressing serious health challenges.
AbbVie (NYSE: ABBV) has successfully completed the acquisition of Syndesi Therapeutics for an upfront payment of $130 million, with potential milestone payments up to $870 million. This strategic move enhances AbbVie's neuroscience portfolio, particularly focusing on the development of the lead molecule SDI-118, aimed at treating cognitive impairments linked to neuropsychiatric disorders and neurodegenerative diseases. SDI-118 is currently undergoing Phase 1b clinical trials, targeting synaptic efficiency to address unmet medical needs in patients.
AbbVie has announced that the FDA has extended its review of SKYRIZI (risankizumab-rzaa) for treating moderate to severe Crohn's disease by three months. This extension is to assess additional data concerning the on-body injector for this new indication. Previously, SKYRIZI was approved for treating moderate to severe plaque psoriasis and active psoriatic arthritis. This ongoing FDA review does not affect existing approved indications.
On February 28, 2022, AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for IMBRUVICA (ibrutinib) to treat pediatric patients aged one year and older with chronic graft versus host disease (cGVHD). A New Drug Application for an oral suspension formulation was also submitted, aiming to provide a more suitable dosage form for younger patients. The iMAGINE clinical trial, which included 59 participants, showed an overall response rate of 78%. If approved, it would be the first FDA-approved treatment option for pediatric cGVHD.