2018 was a pivotal year for oligonucleotide therapeutics
The translation of scientific discoveries into commercially available therapeutics is a long and tedious process often filled with setbacks, and this has been true of oligonucleotide (oligo) therapeutics. For 30 years scientists have worked to deliver oligo based drugs to patients who desperately need them. By October 2017, regulatory agencies had only approved five oligo drugs (1).
Drug developers persevered and saw a string of successes in 2018 that solidified oligo therapeutics as a viable drug platform capable of delivering drugs that benefit patients.
The year started and ended with positive news about vaccines that use oligo adjuvants. In January, Dynavax announced the launch of its two-dose hepatitis B vaccine, HEPLISAV-B™ (2). After multiple setbacks, the FDA finally approved the vaccine in November 2017. Soon after the vaccine’s launch, the Centers for Disease Control and Prevention’s Advisory Committee of Immunization Practices (ACIP) voted unanimously in favor of including HEPLISAV-B™ on its list of recommended products (3). In December 2018, Emergent BioSolutions announced submission to FDA o ...