Industry Insights Healthcare: 23/02/25
In this week’s insights, we discuss three of the latest pharmaceutical approvals in the healthcare industry.
FDA approves the first drug for Niemann-Pick disease, type C
The US Food and Drug Administration (FDA) has approved arimoclomol (Miplyffa) for the treatment of Niemann-Pick disease, type C in adults and children 2 years or older. Arimoclomol, in combination with miglustat, is the first approved drug to treat neurological symptoms linked to NPC, a rare genetic disease seen in 1/100,000-120,000 live births. The approval is based on a clinical trial that showed arimoclomol slowed disease progression in patients with NPC. Common side effects of the drug include upper respiratory tract infections, diarrhoea, and decreased weight.
Newly approved at-home syphilis test promises to save lives
The US Food and Drug Administration (FDA) has lately approved an at-home syphilis test, known as the First To Know Syphilis Test from NOWDiagnostics. This over-the-counter test can detect the infection in 15 minutes with a fingerprick blood sample. According to the FDA’s De Novo premarket review pathway, the test can accurately identify 99.5% of syphilis-negative blood specimens and 93.4% of syphilis-positive blood specimens. The FDA’s approval is timely considering the surge in syphilis cases in recent years in the US. It aims to increase access to STI testing, particularly among vulnerable populations.
FDA approves the first adaptive deep brain stimulation system for Parkinson’s disease
Medtronic has recently announced that the US Food and Drug Administration (FDA) has approved the company’s adaptive deep brain stimulation (aDBS) technology, known as BrainSense Adaptive, for the treatment of Parkinson’s disease. According to investigators from the Stanford University School of Medicine and the Massachusetts General Hospital, the BrainSense Adaptive DBS system can detect, capture, and classify brain signals to provide effective therapy. The researchers state that adaptive DBS may control motor fluctuations, dyskinesias, and other side effects with continuous DBS.
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