Bayer Receives FDA Approval of myBETAapp & BETACONNECT Navigator

Bayer recently announced that the US FDA has approved a supplemental Biologics License Application (sBLA) for myBETAapp and the BETACONNECT Navigator.

With this software in relapsing-remitting multiple sclerosis, people using the electronic BETACONNECT autoinjector to administer BETASERON (interferon beta-1b) can use Bluetooth technology to connect their current autoinjector to the new myBETAapp on their mobile device or computer. Patients have the opportunity to share their injection data with their BETA Nurse and healthcare team. Viewing this data through the BETACONNECT Navigator may be a useful tool for the healthcare team to gain insights into patients’ injection history and provide support to those taking BETASERON.

“Since introducing the first FDA-approved treatment option for relapsing remitting multiple sclerosis patients more than 2 decades ago, we’ve listened closely to the community to understand their needs and how we can support them,” said Mark Rametta, DO, FACOI, FACP, Bayer’s Medical Director for Neurology. “The myBETAapp and BETACONNECT Navigator add to the services that we’ve developed based on patient feedback, including 24/7 access to nurse support and the first and only electronic autoinjector for patients taking BETASERON.”

Patients should not take BETASERON (interferon beta-1b) if they are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol. BETASERON can cause serious side effects, such as liver problems, including liver failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, bruising easily or bleeding problems. A healthcare provider will do blood tests to check for these problems while the patient is taking BETASERON.

Patients using other injection methods to take their BETASERON can also manually enter injection information into the myBETAapp and participate in the sharing of data with their BETA Nurse and healthcare team.

“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 healthcare team,” said Daniel Kantor, MD, FAAN, and President Emeritus, Florida Society of Neurology.

The myBETAapp will be available for free download at the Apple app store, Google Play or Betaseron.com. Patients enrolled in BETAPLUS, Bayer’s comprehensive patient support program, can speak directly to a BETA Nurse, who is specially trained in MS.

The BETACONNECT autoinjector, myBETAapp and the BETACONNECT Navigator were designed and developed by Medicom Innovation Partner, headquartered in Struer, Denmark.

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.