FDA Approves Bayer’s myBETAapp™

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™.  The myBETAapp joins the growing field of medical mobile applications, which the FDA predicts will reach 1.7 billion smartphone or tablet users by 2018.

According to Bayer, the myBETAapp connects their BETACONNECT autoinjector (for delivering BETASERON®, a therapeutic agent for multiple sclerosis) to a patient’s mobile device or computer, and the BETACONNECT Navigator functions as a tool to view data uploaded by the myBETAapp.

According to the myBETAapp user instructions, the application will:

  • Display scheduled injections according to an injection routine
  • Allow the user to determine when an injection is scheduled
  • Display suggested injection sites based on the injection sites shown in the prescribing information for BETASERON®
  • Display a monthly calendar of recorded, missed, and scheduled injections
  • Transfer and sync data recorded by the autoinjector to the corresponding injection in the calendar
  • Send a notice to record injection data to the patient via email

In the press release, Bayer describes the myBETAapp and BETACONNECT Navigator as allowing further connection between the patient and the healthcare team by, with the patient’s permission, providing access to the patient’s injection history. The application is also advertised as providing further connectivity to a BETA Nurse for patients enrolled in BETAPLUS®, Bayer’s patient support program.

According to Dr. Kantor, President Emeritus, Florida Society of Neurology:

The myBETAapp and BETACONNECT Navigator work cohesively together to support communication and connection between people living with relapsing remitting multiple sclerosis and their BETA Nurse and health care team.

Bayer reports that the myBETAapp will be available for free download from the Apple app store, Google Play Store, or Betaseron.com by mid-July 2017.

 

Brandon Smith
Brandon Smith is an associate in our Orange County office. His practice is focused on patent litigation and prosecution. Mr. Smith earned his Bachelor's of Science in Biomedical Engineering at California Polytechnic University, San Luis Obispo. Mr. Smith received his J.D. from the University of San Diego School of Law where he was Editor-in-Chief of Volume 52 of the San Diego Law Review. Mr. Smith was a summer associate with the firm in 2014 and joined the firm as an associate in 2015.
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