News FDA Accepts Bayer’s Supplemental BLA for myBETAapp and BETACONNECT Navigator for MS Patients FDA Accepts Bayer’s Supplemental BLA for myBETAapp and BETACONNECT Navigator for MS Patients by Patricia Silva, PhD | December 15, 2016 Share this article: Share article via email Copy article link The U.S. Food and Drug Administration (FDA) has accepted Bayerās filing of a supplemental biologics license application (sBLA) for two products designed to improve the lives of people withĀ multiple sclerosis (MS): myBETAapp and the BETACONNECT Navigator. Bayer created the BETACONNECT systemĀ to increase patient treatment compliance and improve therapeutic results. BETACONNECT’s patient-centered auto-injector device is gentler than normal spring-loaded mechanical devices, and was specifically designed for the delivery of Betaseron (interferon beta-1b). TheĀ myBETAapp is a free mobile app that helps patients schedule, track, and record their Betaseron injections whenever itās convenient for them. Patients can share their information with their healthcare providers, personalize their injection sites, track trends on their well-being over time and communicate with the Betaconnect autoinjector. The BETACONNECT Navigator is a web-based application that gives clinicians the ability to review their patients’ injection history.Ā The BETACONNECT Navigator interfaces with the Betaconnect system for healthcare providers, just as myBETAapp does for patients. “Mobile health technology is a growing area in healthcare communication today,” Mark Rametta, DO, Bayerās medical director for neurology, said in a press release. āThe filing of myBETAapp and the BETACONNECT Navigator supports our continued commitment to meeting the needs of patients taking Betaseron to treat their relapsing forms of MS. We have proudly supported the MS community for more than 20 years.ā In 1993, Betaseron became the first disease-modifying drug to be approved by the FDA for patients with relapsing forms of MS. It works by reducing the ability of immune system cells to enter the central nervous system, thereby reducing inflammation and disease severity. Because of its mode of action, Betaseron is used to reduce the number of relapses in people with relapsing forms of MS, including those who have had their first symptoms of MS and have an MRI that is consistent with a diagnosis of MS. Betaseron is not a cure for MS but might slow down the frequency of flare-ups (full prescribing information is available here). 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 Bayer, BETACONNECT, BETASERON, FDA
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