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This year has been exciting for clinical research. Our ENCORE sites completed 65 clinical trials (studies), and the FDA approved 66 new medications and vaccines nationwide. There is a long time between when a research organization or site, such as ours, completes a study and when a medication is ready for FDA review. Out of the 66 new medications or vaccines that were approved this year, ENCORE sites conducted seven of those clinical trials. That means all of you fantastic research volunteers helped get seven new medications or vaccines to market! In this article, we’ll review this year’s approvals and what they mean.

Three new vaccines that received FDA approval this year had trials at ENCORE sites. Arexvy and Abrysvo were both approved for the treatment of Respiratory Syncytial Virus (RSV) in adults. This disease hospitalizes 177 thousand adults over 65 each year and causes over ten thousand deaths. Arexvy was the first vaccine approved against RSV in adults, and Abrysvo is intended for both prevention and treatment of RSV and is approved for use in pregnant women. Arexvy was studied at the Westside Center for Clinical Research and Abrysvo at Nature Coast Clinical Research – Crystal River. Ixchiq is the world’s first vaccine to be approved for Chikungunya. Chikungunya is spread to people by infected mosquitoes and causes fevers and joint pain. St. Johns Center for Clinical Research participated in two phase III clinical trials for Ixchiq.

Two more ENCORE-researched medications approved this year were the first of their kind. Vowst has become the first medication to become FDA-approved for the treatment of C. difficile, also known as C. diff. C. difficile is a major health threat and causes colon inflammation. ENCORE Borland Groover Clinical Research investigated Vowst in the ECOSPOR trials. Veozah (fezolinetant) is the first non-hormonal treatment for moderate to severe vasomotor symptoms in women with menopause. These symptoms include hot flashes and night sweats, and Veozah targets the temperature centers of the brain to help with these symptoms. Three ENCORE research sites participated in the SKYLIGHT trials to investigate Veozah, Fleming Island Center for Clinical Research, St. Johns Center for Clinical Research, and Nature Coast Clinical Research – Crystal River.

Two medications were approved, which may help with established diseases. Rinvoq (upadacitinib) is a daily pill for those with Crohn’s disease, an autoimmune disorder. Rinvoqwas the first oral treatment for Crohn’s disease to be approved. It was studied at ENCORE Borland Groover Clinical Research. Inpefa (sotagliflozin) has been approved as a daily pill to reduce cardiovascular death, hospitalization, and urgent heart failure by 33% in patients with heart failure. It was studied at the Jacksonville Center for Clinical Research.

We at ENCORE Research Group are very excited about a year of amazing approvals. It validates the hard work and effort of all of our research staff and doctors, and – most importantly – it goes to show just how important our patient volunteers are! With the help of these heroes, we have new and effective options to help with six different diseases. Many thanks to everyone who has participated in any of our clinical trials, and we’ll see you next year!

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References:

Abbvie. (18 May, 2023). U.S. FDA Approves RINVOQ® (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active Crohn’s Disease in Adults. https://news.abbvie.com/news/press-releases/us-fda-approves-rinvoq-upadacitinib-as-once-daily-pill-for-moderately-to-severely-active-crohns-disease-in-adults.htm

Astellas. (13 May, 2023). Astellas’ VEOZAHTM (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause. https://www.astellas.com/en/system/files/news/2023-05/20230513_en_1.pdf

GSK plc. (3 May, 2023). US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-arexvy-the-world-s-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/

Lexicon Pharmaceuticals. (26 May, 2023). Lexicon Announces FDA Approval of INPEFA™ (Sotagliflozin) for Treatment of Heart Failure. https://www.lexpharma.com/media-center/news/2023-05-26-lexicon-announces-fda-approval-of-inpefa-sotagliflozin-for-treatment-of-heart-failure

Schneider, M., Narciso-Abraham, M., Hadl, S., McMahon, R., Toepfer, S., Fuchs, U., … & Wressnigg, N. (2023). Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. The Lancet. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00641-4/fulltext

Seres Therapeutics, Nestle Health Science. (26 April, 2023). Seres Therapeutics and Nestlé Health Science Announce FDA Approval of VOWST™ (fecal microbiota spores, live-brpk) for Prevention of Recurrence of C. difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI. https://www.nestlehealthscience.us/stories/seres-therapeutics-and-nestle-health-science-announce-fda-approval-vowst

Velena SE. (10 November, 2023). Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ®. https://valneva.com/wp-content/uploads/2023/11/2023_11_10_BLA_Approval_PR_EN_Final_.pdf

U.S. Food & Drug Administration. (27 November, 2023). 2023 Biological License Application Approvals. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-approvals

U.S. Food & Drug Administration. (19 December, 2023).  Novel Drug Approvals for 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023