The FDA has approved the fully human monoclonal antibody bezlotoxumab (Zinplava – Merck) for use with antibacterial drug treatment to reduce recurrence of Clostridium difficile infection (CDI) in adults with CDI at high risk for recurrence. It is the first drug to be approved for this indication.
CDI — CDI is the most common infectious cause of healthcare-associated diarrhea in adults. The incidence and severity of CDI have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027).1 The recurrence rate after an initial episode of CDI is typically 20-25%. Patients who develop one recurrent episode have up to a 35% chance of having another one, and patients with at least three CDI episodes have up to a 65% chance of additional recurrences.2
The FDA has approved nusinersen (Spinraza – Biogen) for treatment of spinal muscular atrophy (SMA), a hereditary neurodegenerative disease that occurs in about one in every 10,000 births.1 It is the first drug to be approved in the US for this indication.
SPINAL MUSCULAR ATROPHY — SMA is an autosomal recessive neuromuscular disorder in which degeneration of alpha motor neurons in the anterior horn cells of the spinal cord leads to muscle weakness and atrophy. Most cases are caused by a homozygous deletion or ...