FDA Accepts Bayer’s Supplemental BLA for myBETAapp and BETACONNECT Navigator for MS Patients

The U.S. Food and Drug Administration (FDA) has accepted Bayer’s filing of a supplemental biologics license application (sBLA) for two products designed to improve the lives of people with multiple sclerosis (MS): myBETAapp and the BETACONNECT Navigator.

Bayer created the BETACONNECT system 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).

The myBETAapp is a free mobile app that helps patients schedule, track, and record their Betaseron injections whenever it’s 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. 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, Bayer’s medical director for neurology, said in a press release. “The 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.”

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).