AbbVie | September 19, 2022
AbbVie announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of risankizumab for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.
"We continue to raise the bar in researching treatments for immune-mediated gastroenterological conditions through more stringent and innovative clinical trial design, such as the first time a Phase 3 trial has reported co-primary endpoints, endoscopic response and clinical remission. With the recent CHMP recommendation for risankizumab in Crohn's disease, we're getting closer toward helping patients find sufficient disease control for this disruptive condition."
Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, AbbVie
AbbVie's application for the approval of risankizumab in Crohn's disease is supported by data from three Phase 3 clinical trials — ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study).1,2 Across all three studies, significantly more patients treated with risankizumab achieved the co-primary endpoints of endoscopic response and clinical remission.1,2,5-10 This includes statistically significant improvements in these endpoints at week 12 compared to placebo with 600 mg intravenous infusions for the ADVANCE and MOTIVATE induction studies.1,8,9 Additionally, a significantly greater proportion of patients treated with risankizumab 360 mg subcutaneous injections achieved endoscopic response and clinical remission at 52 weeks compared to placebo (patients treated with placebo after risankizumab induction) in the FORTIFY maintenance study.2,10 Safety results of risankizumab in Crohn's disease were consistent with the known safety profile of risankizumab, with no new safety risks observed.1,2,8-13
"Living with Crohn's disease can pose many challenges and significantly impact a patient's health-related quality of life," said Marc Ferrante, M.D., Ph.D., Department of Gastroenterology and Hepatology, University Hospitals Leuven, Belgium. "Risankizumab could be an encouraging option for adult patients that continue to have moderately to severely active Crohn's disease and I look forward to the European Commission's final decision."
Use of risankizumab in Crohn's disease is not approved in the European Union, and its safety and efficacy remain under evaluation.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.3,4 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.3,4 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.14,15
About the ADVANCE and MOTIVATE Inductions
Studies, and the FORTIFY Maintenance Study1,2,8-10
The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of risankizumab 600 mg and 1200 mg as induction therapy, and risankizumab 180 mg and 360 mg as maintenance therapy in subjects with moderately to severely active Crohn's disease. Topline results of the ADVANCE and MOTIVATE induction studies were announced in January 2021 and topline results of the FORTIFY maintenance study were announced in June 2021.
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.11,16 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.11,16 The approved dose for SKYRIZI for moderate to severe plaque psoriasis and active psoriatic arthritis in the European Union is 150 mg (either as two 75 mg prefilled syringe injections or one 150 mg prefilled pen or prefilled syringe) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter.11 The use of risankizumab in Crohn's disease is not approved in the European Union and its safety remains under review with the global regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.12,13,17
EU Indications and Important Safety Information about SKYRIZI® (risankizumab)11
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.
SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper respiratory infections. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.
About AbbVie in Gastroenterology
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.
AllianceRx Walgreens Pharmacy | September 28, 2022
AllianceRx Walgreens Pharmacy has received exclusive access to Phospholine Iodide® from Fera Pharmaceuticals. Phospholine Iodide is used to help reduce elevated intraocular pressure of glaucoma and for accommodative esotropia in children.
"AllianceRx Walgreens Pharmacy is excited to be able to offer this invaluable therapeutic option to help correct these chronic and rare ophthalmologic conditions. These patients deserve access to this life-changing therapy that may actually preserve their vision. Our manufacturer partners know we offer resources to help patients stay on therapy and yield the best possible outcomes."
Lisa Mymo, vice president, pharma and financial services at AllianceRx Walgreens Pharmacy
As one of the nation's largest specialty and home delivery pharmacies, AllianceRx Walgreens Pharmacy has direct access to the majority of limited distribution drugs on the market. In addition to Phospholine Iodide, the following medications are also available through AllianceRx Walgreens Pharmacy:
Camzyos manufactured by Bristol Myers Squibb, treats adults with a rare heart condition known as symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.
Vivjoa manufactured by Mycovia Pharmaceuticals, Inc., treats postmenopausal and permanently infertile women with recurrent vaginal yeast infections.
About AllianceRx Walgreens Pharmacy
AllianceRx Walgreens Pharmacy provides hope and care for better tomorrows to patients with rare diseases and chronic conditions by delivering medications from its specialty and home delivery pharmacies. Our advanced analytical capabilities, pharmacy expertise and technology solutions enable providers, pharmaceutical manufacturers, and health plans to deliver optimal health outcomes. Through personalized care and clinical programs, along with access to the leading number of limited distribution drugs, patients can get back to what matters most. Headquartered in Orlando, Florida, the company holds several national pharmacy accreditations and has team members across the United States.
Atomwise | August 22, 2022
Atomwise, a leader in using artificial intelligence (AI) for small molecule drug discovery, announced that it has established a strategic and exclusive research collaboration with Sanofi that will leverage its AtomNet® platform for computational discovery and research of up to five drug targets.
The Atomwise approach shifts the mode of drug discovery away from serendipitous discovery and toward search based on structure, making the drug discovery process more rational, effective, and efficient. The AtomNet platform incorporates deep learning for structure-based drug design, enabling the rapid, AI-powered search of Atomwise’s proprietary library of more than 3 trillion synthesizable compounds.
“At Sanofi, we are committed to bringing higher quality medicines to patients faster, empowered by our advanced AI drug discovery engine. We are excited to partner with Atomwise, given their leadership in the field of virtual screening and AI-based molecular design. Together, we aim at making the drug discovery process more efficient and effective in particular when very limited information is available to support drug design.”
Frank Nestle, Global Head of Research and Chief Scientific Officer at Sanofi
As part of this agreement, Sanofi will pay Atomwise $20 million upfront to identify, synthesize, and advance lead compounds for up to five targets which will be exclusive to Sanofi. Subsequent payments pegged to key research, development, and sales milestones could total more than $1 billion. In addition, tiered royalties have been established for products developed through the collaboration.
“At Atomwise, our mission is to use our unique technology to make better medicines, faster, by unlocking targets that have been inaccessible to traditional small molecule discovery approaches,” said Abraham Heifets, co-founder and CEO of Atomwise. “We are pleased to enter into this collaboration with Sanofi, which serves as continued validation of the important role that AI-powered platforms will play in accelerating the discovery of new therapies for diseases and conditions that may have gone untreated due to challenging or uncharacterized drug targets.”
Atomwise is a technology-enabled pharmaceutical company leveraging the power of AI to revolutionize small molecule drug discovery. The Atomwise team invented the use of deep learning for structure-based drug design; this technology underpins Atomwise’s best-in-class AI discovery engine, which is differentiated by its ability to find and optimize novel chemical matter. Atomwise has extensively validated its discovery engine, having demonstrated the ability to find compounds with therapeutic potential for biological targets in 90% of internal programs and more than 70% of the company’s 270 academic collaborations, including across a wide variety of protein types and multiple “hard to drug” targets. Atomwise is building a wholly-owned pipeline of small-molecule drug candidates, with three programs in lead-optimization and over 30 programs in discovery. The company has raised over $194 million from leading venture capital firms and collaborations to advance its mission to make better medicines, faster.