FDA Accepts Bayer’s BETACONNECT License Application for Relapsing-Remitting Multiple Sclerosis

Bayer HealthCare recently announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a supplemental Biologics License Application (sBLA) for BETACONNECT for the treatment of relapsing-remitting multiple sclerosis (MS). BETACONNECT is a new drug delivery option for patients under Bayer’s BETASERON® (interferon beta-1b) therapy.

MS is a chronic, progressive neurodegenerative disorder that results from an attack on the central nervous system by the body’s own immune system, causing inflammation and damage to the myelin layer that covers and protects neurons. Myelin loss leads to impairment in signal transmission along nerve fibers, affecting motor function (like coordination, balance, speech and vision), causing irreversible neurological disability and partial or complete paralysis. It is estimated that more than 2.3 million people in the world suffer from MS.

Injectable beta-interferons are the most widely prescribed immunomodulatory drugs for the most frequent form of the disease, relapsing-remitting MS. Bayer’s BETASERON is a medicine based on interferon beta-1b that is prescribed to reduce the number of relapses in relapsing-remitting MS patients. MS cannot be cured by BETASERON, but Bayer notes that it may reduce the frequency of clinical exacerbations related to the disease.

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In order to increase patient treatment compliance and consequently improve therapeutic results, Bayer developed BETACONNECT, a completely electronic patient-centered auto-injector that offers a gentler, lower-force injection in comparison to standard, spring-loaded mechanical devices. According to Bayer, BETACONNECT features an intuitive user interface, allows automatic needle insertion and retraction and is characterized by an ergonomic design, allowing one-handed injections. Needle insertion depth, injection speed and injection reminders can all be customized by the patient. As part of a computerized system, patients using the BETACONNECT can also upload their injection progress to a secure website, to which their healthcare providers can have access to and, if necessary, provide personalized support.

“This filing underscores Bayer’s continued, longstanding commitment to meeting the needs of patients taking BETASERON to treat their relapsing forms of MS,” said the Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals Dr. Dario Mirski in a news release. “We have proudly supported the MS community for more than 20 years.”