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Inpefa, Paxlovid, The Link BCI, Xacduro, Brixadi, Opvee
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In this episode, we discuss the latest FDA approvals from May 22 to May 26, 2023. Here are the key highlights:
Inpefa (sotagliflozin) has received FDA approval as a once-daily oral tablet for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus. Common side effects include urinary tract infection, volume depletion, diarrhea, and hypoglycemia.
Paxlovid, a combination of nirmatrelvir and ritonavir tablets, has been granted full approval as an oral antiviral treatment for adults with mild-to-moderate COVID-19 at high risk for severe illness. Clinical data suggests significant risk reduction in hospitalizations and deaths with Paxlovid use.
Neuralink, founded by Elon Musk, has received FDA approval for its brain implant called "The Link." This brain-computer interface aims to help patients with severe paralysis regain the ability to control external technologies using neural signals.
Xacduro (sulbactam/durlobactam injection) has been approved for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii–calcoaceticus complex. Xacduro is the first pathogen-targeted therapy approved for this type of pneumonia.
Brixadi (buprenorphine) Extended-Release Subcutaneous Injection has received FDA approval for the treatment of moderate-to-severe opioid use disorder. It is available in weekly and monthly injection formulations and should be used as part of a comprehensive treatment plan.
Opvee, the first nalmefene hydrochloride nasal spray, has been approved for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients. Nalmefene is an opioid receptor antagonist that can reverse the effects of opioid overdose if administered quickly.
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