News MS Drug Under Study No Longer Being Given in Higher Doses to Patients MS Drug Under Study No Longer Being Given in Higher Doses to Patients by Patricia Silva, PhD | January 7, 2016 Share this article: Share article via email Copy article link Teva Pharmaceutical Industries Ltd. and Active Biotech have discontinued the use of higher doses of the drug laquinimod in two ongoing multiple sclerosis (MS) studies. The decision was based on a recommendation byĀ the Data Monitoring Committee (DMC)Ā that isĀ supervising the clinical trials afterĀ cardiovascular events, none of which were fatal, were reported in eight patients. The DMC identified anĀ imbalance in the number of cardiovascular events being reported, according to a press release.Ā Seven of the events were detected in Ā patientsĀ receiving 1.2 mg ofĀ laquinimod every day for the treatment of relapsing-remitting MS (RRMS) in the CONCERTO clinical trial, which has Ā 2,199 patients enrolled. No events were observed in the 0.6 mg laquinimod or placebo patient groups in this Phase 3Ā study. The eighth cardiovascular event was reported in theĀ 1.5 mg daily-dose arm of the ARPEGGIO clinical trial assessing laquinimod in primary progressive MS (PPMS). In total, the Phase 2 ARPEGGIO trial hasĀ 191 patients currently enrolled. Teva is notifyingĀ all sites in both trials to stop the administration of laquinimod at higher doses, and encouraging participants to continue the follow-up part of the studies.Ā Laquinimod is a once-daily oral, CNS-active immunomodulator with a novel mechanism of action being developed as a possibleĀ treatment for relapsing-remitting MS, primary-progressive MS, and Huntington’s disease. The DMC did not identify cardiovascular events atĀ the lower laquinimod dose, butĀ recommends long-term monitoring. Both the CONCERTO and ARPEGGIO trials will continue the lower-dose arms (0.6 mg a day) and all participants will be givenĀ an update to confirm participation re-consent. Teva has completed large trials and is currently doing long-term extension studies at the 0.6 mg dose level without cardiovascular concerns. Teva, headquartered in Israel, is a leading global pharmaceutical company developing innovative treatments for disorders affecting the central nervous and the respiratory systems. The company, though a licensing agreement, has global rights to develop and market laquinimod, discoveredĀ byĀ Active Biotech. Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags Active Biotech, Huntington's disease, Laquinimod, primary progressive MS (PPMS), relapse-remitting multiple sclerosis (RRMS), Teva
April 19, 2024 News by Lindsey Shapiro, PhD AAN 2024: Long-term data support early Kesimpta start in relapsing MS
April 18, 2024 Columns by Benjamin Hofmeister Learning how to write a ‘SOAP’ note feels different after an MS diagnosis
April 18, 2024 News by Marisa Wexler, MS AAN 2024: Sustained myelin, nerve cell gains with long-term CNM-Au8