FDA approves Bayer’s Bluetooth-enabled auto-injector for multiple sclerosis


FDA has approved a supplemental Biologics License Application (sBLA) for Bayer’s myBETAapp and BETACONNECT Navigator for multiple sclerosis (MS) patients

FDA has approved a supplemental Biologics License Application (sBLA) for Bayer’s myBETAapp and BETACONNECT Navigator for people living with relapsing-remitting MS (RRMS).

According to the National Multiple Sclerosis Society, MS is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and the body. The most common type of MS, affecting about 85% of patients, is relapsing-remitting MS (RRMS), characterized by clearly defined attacks of new or increasing neurologic symptoms followed by periods of partial or complete recovery.

Betaseron (interferon beta-1b, Bayer) is a subcutaneously injected medication indicated to reduce the frequency of clinical exacerbations in people with relapsing forms of MS; it will not cure the disease but may decrease the number of relapses. The first injection of Betaseron should be administered under the supervision of a healthcare professional but after this first injection, patients can be trained to properly inject Betaseron on their own.

In 2015, FDA approved BETACONNECT, an electronic auto-injector to be used with Betaseron in the treatment of RRMS. The auto-injector allows patients to customize injection speed and depth, has a back-up reminder function that lets patients know when it’s time for their next injection, and performs automatic needle insertion and retraction with a visual and audio end-of-dose indication letting patients know when their injection is complete.

With the new myBETAapp and BETACONNECT Navigator, patients can now use Bluetooth technology to connect their BETACONNECT auto-injector to the new application on their phone or computer. According to Bayer, myBETAapp includes features to help organize and track injection data including the ability for patients to set reminder alerts for injections. BETACONNECT Navigator is the software used to share injection information with the patients’ BETA Nurse and healthcare team. Viewing this data may be a useful tool for the healthcare team to gain insight into the patients’ injection history and provide proactive support.

"Patients using other injection methods other than the auto-injector to take their Betaseron can manually enter their injection information into the myBETAapp to allow sharing of data," said Mark Rametta, D.O., FACOI, FACP, Bayer's medical director for Neurology.

Additionally, patients enrolled in BETAPLUS can speak directly to a BETA Nurse specially trained in MS. According to the manufacturer, BETAPLUS is Bayer’s comprehensive support program offered to people with RRMS throughout their treatment with Betaseron. It provides innovative patient support, treatment tools, as well as 24/7 access to an MS-trained BETA Nurse who gets to know the patients, follows up and guides them to resources that can help with treatment.

The BETACONNECT auto-injector, myBETAapp, and the BETACONNECT Navigator were designed and developed by Medicom Innovation Partner. The myBETAapp with be available for free download through the Apple app store, Google Play or Betaseron.com.

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