A variety of drugs and drug-biologics have been making headlines in the spine field in the past year. Here are seven products that have received regulatory approval or are undergoing clinical trials for the treatment of spinal conditions:
1. In September, biopharmaceutical company AbbVie received Fast Track designation for elezanumab, a drug for the treatment of patients with spinal cord injury. Elezanumab, a monoclonal antibody, intends to block a molecule that can hinder neuronal regeneration and functional recovery after central nervous system damage.
2. In August, the FDA approved the third drug for the treatment of neuromyelitis optica spectrum disorder, which affects the optic nerves and spinal cord. Enspryng, developed by Genentech, was shown to be a safe and effective treatment for NMOSD in clinical trials.
3. Genentech also received FDA clearance for Evrysdi, a drug for spinal muscular atrophy in adults and children 2 months of age and older. Genentech is the third company to receive approval for an SMA drug. Evrysdi has a market price of $340,000 annually and is based on the weight of the patient.
4. In May, the European Commission approved Zolgensma, Novartis' $2.1 million gene therapy drug for SMA, for infants and children up to 46 pounds. Priced at $2.1 million, Zolgensma has been dubbed "the world's most expensive drug" and was cleared by the FDA in June 2019.
5. Orthobiologics company Kuros Biosciences is evaluating Fibrin-PTH for transforaminal lumbar interbody fusion in patients with degenerative disc disease. Fibrin-PTH is a drug-biologic that facilitates bone growth through the induction of osteoprogenitor cell differentiation, enhancement of osteoblast proliferation and increasing the lifespan of bone-forming cells.
6. Alume Biosciences is investigating the use of a nerve imaging drug for spine surgery. Alume's ALM-488 peptide-dye conjugate is designed for the fluorescent highlighting of nerves during head and neck procedures. The product binds to the extracellular matrix of nerves, allowing real-time nerve illumination intraoperatively.
7. Myeliviz, a drug to help diagnose multiple sclerosis in its earlier stages, is being evaluated by Cleveland Clinic in clinical trials. The drug aims to provide new evidence to help diagnose MS and evaluate the scope of damage inflicted on the central nervous system.