Michael E. Severino
Vice Chairman and President at AbbVie
Thank you, Jeff. I'll start with immunology, where we had several regulatory updates and data readouts for both Rinvoq and Skyrizi across therapeutic areas. Following successful completion of the registrational programs for Rinvoq in ulcerative colitis, and Skyrizi in Crohn's disease, we submitted our regulatory applications for each asset in their respected indications. We saw a very strong data for both Rinvoq and Skyrizi as induction and maintenance treatments in UC and Crohn's respectively. And based on these results, we believe both drugs have the potential to become a highly effective, differentiated therapies in these indications. We anticipate approval decisions for both in 2022. Earlier this month, we announced positive top line results from our Phase three SELECT-AXIS two program for Rinvoq in axial SpA, which included data from two standalone studies. One for ankylosing spondylitis patients who had an inadequate response to biologics. And another for patients with non-radiographic axial SpA. In the ankylosing spondylitis biorefractory study, RINVOQ performed very well, demonstrating significantly greater improvements in signs and symptoms, as well as physical function and imaging endpoints compared to placebo. We saw levels of efficacy in this difficult to treat refractory population similar to those more typically observed in bio-naive patients. These results will be added to our submission package for RINVOQ in AS which is currently under review by the FDA. In a non - radiographic axial spot study, RINVOQ also performed very well, meeting the primary and key secondary endpoints. We plan to submit our regulatory applications in this indication later this quarter as well. RINVOQ's safety profile in these actual spot trials was consistent with previous studies, and there was no evidence for increased risk of DVT, PE, MACE events, or malignancies in either study. Based on the data generated in the select access program, we believe RINVOQ has the potential to improve care for patients suffering from Axial SpondyloArthritis by providing sustained disease control and rapid and durable pain reduction as well as improving function.
As you're likely aware, in September, the FDA communicated that they will require new warnings for JAK inhibitors, including RINVOQ and their use will be limited to certain patients who have not responded to or cannot tolerate anti - TNFs. We continue to work with the FDA regarding updated labeling language for the RA indication, while simultaneously engaging with the agency on our files for atopic dermatitis, psoriatic arthritis, and ankylosing spondylitis. We remain confident in our submission packages for these three new indications and continue to expect approvals following completion of the RA label update. In the area of oncology, we continue to make good progress advancing all stages of our pipeline. We're nearing completion of several indication expansion programs for VENCLEXTA. In our study in previously untreated higher-risk MDS patients, which recently received a breakthrough therapy designation, we expect to make a data cut early next year to include 6-month follow-up data for duration of response. Based on this data cut, we plan to submit our regulatory applications to the FDA in the first half of 2022, for an accelerated approval. We continue to make good progress with Venclexta in the Canova trial, which is evaluating Venclexta in relapsed refractory multiple myeloma patients with a t(11;14) mutation. VENCLEXTA has shown strong anti - myeloma activity in this biomarker-defined population and if successful, has an opportunity to play an important role in the treatment paradigm for multiple myeloma. We expect a data readout from this event-driven trial next year. In our early to mid-stage hem/onc pipeline, we continue to expand the cohorts in the aducanumab Phase one, two studies in diffuse large B-cell lymphoma and follicular lymphoma. And we're evaluating aducanumab as both a monotherapy and in combinations. We expect to see data from both the monotherapy and combo studies next year.
And we will discuss the monotherapy data with regulators regarding a file for accelerated approval. We also recently began the dose escalation stage of the Phase 1b studies for [Indecipherable] in AML, MDS and multiple myeloma. And ABBV -383, our BCMA-CD3 bispecific antibody, is currently in the expansion stage of its Phase one study in multiple myeloma patients. And we expect to begin registrational phase three studies next year. Moving to Neuroscience, where we had several notable pipeline events since our last earnings call. In September, we received FDA approval for Qulipta, the only oral CGRP specifically designed as a preventative treatment for migraine. We're very pleased with the label, which reflects Qulipta a strong benefit risk profile, and is supported by a robust clinical development program. In our registrational program, which evaluated Qulipta in nearly 2,000 patients suffering from episodic migraine, treatment with Qulipta resulted in a significant reduction in mean monthly migraine days compared to placebo. And approximately 60% of patients achieved at least a 50% reduction in the migraine days. We think these data compare favorably to other preventative migraine treatments on the market, and believe our new oral treatment option will be competitively positioned in the prevention market. Our migraine portfolio now includes Ubrelvy for acute treatment of migraine, Qulipta for preventative treatment of episodic migraine, and Botox for preventative treatment of chronic migraine. With this distinct portfolio, AbbVie is uniquely positioned to address the full spectrum of this complex and debilitating disease. This morning, we announced top-line results from two Phase three studies evaluating Vraylar as an adjunctive treatment in major depressive disorder. In the 301 study, a 1.5 milligram a day Vraylar dose met the primary endpoint demonstrating a clinically meaningful improvement in total MADRS score compared to placebo at Week six with a highly statistically significant p-value of 0.005.
In this study, the three milligram Vraylar dose did not reach statistical significance, but it did show a clear trend toward improvement with a nominal p-value of approximately 0.073 at Week six. In the second phase three trial, the 302 study, neither Vraylar doses met the primary endpoint of change in total MADRS score at week six. But both the 1.5 and three milligram doses demonstrated clear trends toward a clinically meaningful benefit at weeks two and four, with nominal P values less than 0.05 for a number of comparisons. Additionally, as a reminder, we had one prior positive registrational Phase 2B study where Vraylar demonstrated efficacy in MDD when added to ongoing antidepressant treatment. Based on precedent in the field and the totality of the data, we believe we have a viable regulatory pathway for Vraylar as an adjunctive treatment in major depressive disorder. We plan to engage with regulatory agencies to discuss these results and expect to spend our regulatory application to the FDA in the first half of next year. We also recently announced positive top-line results from a phase three study comparing our novel subcutaneous levodopa/carbidopa delivery system, ABBV -951 to oral levodopa/carbidopa in patients with advanced Parkinson's disease. In this pivotal study, treatment with 951 resulted in clinically meaningful improvements in on time without troublesome dyskinesia, as well as similar improvements in normalized off time compared to oral Levodopa or Carbidopa. We're very pleased with these results, which we believe support our view that 951 has the potential to become a transformative improvement to current treatment options for patients with advanced Parkinson's disease. We plan to submit our regulatory application next year with approval decisions anticipated in the U.S. and Europe in early 2023. And in Eye Care, we announced the partnership with REGENXBIO to develop and commercialize RGX -314, a potential gene therapy for the treatment of wet AMD, diabetic retinopathy, and other chronic retinal diseases.
RGX-314 is a very attractive addition to our pipeline, and complements our Eye Care portfolio with a potential flagship product in retinal disease. REGENXBIO recently presented initial data from two Phase two studies evaluating RGX -314 in wet AMD and diabetic retinopathy, using in-office suprachoroidal delivering. While early, these results are encouraging, with RGX -314 demonstrating efficacy at the lowest dose. And the study showing that the drug and delivery method both appear to be well tolerated. Also, in eye care, we continue to expect approval for Viewty [Phonetic] shortly, formerly known as AGN-190584 for the treatment of symptoms associated with Presbyopia. This once-daily eye-drop was developed to help address presbyopia that is often corrected through reading glasses. And once approved via convenient on-demand solution for patients with mild-to-moderate presbyopia who may not want to wear reading glasses. This has been a very productive year thus far for our R&D organization, and we anticipate several additional milestones in the coming months. We expect this momentum to continue into next year, which is looking to be a milestone filled year for AbbVie as well.
With that, I'll turn the call over to Rob for additional comments on our third quarter performance and financial outlook. Rob.