Here is information on the latest US FDA approvals, the week of May 22 – May 26, 2023. Please subscribe, rate and review. Thank you!
Inpefa (sotagliflozin) for heart failure
The FDA has approved Inpefa (sotagliflozin), a sodium-glucose co-transporter (SGLT) type 1 and type 2 inhibitor. Sotagliflozin is a once-daily oral tablet indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. According to a press release from the manufacturer Lexicon Pharmaceuticals, the approval is based on two Phase 3 trials: SOLOIST-WHF (Worsening Heart Failure) and SCORED. Most common adverse reactions with an incidence ≥ 5% were urinary tract infection, volume depletion, diarrhea, and hypoglycemia Sotagliflozin inhibits both SGLT1 and 2, SGLT2 is responsible for glucose reabsorption by the kidney and SGLT1 is responsible for glucose absorption in the gastrointestinal tract. Other SGLT inhibitors include bexaglifloxin canagliflozin, dapagliflozin, ertugliflozin and empagliflozin.
Paxlovid (nirmatrelvir tablets and ritonavir tablets) for COVID-19
The FDA has granted full approval to Pfizer’s oral antiviral COVID-19 treatment Paxlovid (a combination of nirmatrelvir and ritonavir tablets). The FDA has approved the two-drug therapy to treat adults with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid initially received emergency use authorization from the FDA in late 2021. The approval is based on data from the EPIC (Evaluation of Protease Inhibition for COVID-19) clinical development program. Based on the relative risk reduction seen across both clinical and real-world data, the FDA estimated that each week, more than 1,500 lives could be saved, and 13,000 hospitalizations could be avoided with Paxlovid use in eligible patients. One of the components, nirmatrelvir is designed to block the activity of Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir.
Brain implant “The Link” for Paralysis
Neuralink, a company founded by Elon Musk, has received approval from the FDA to conduct its first in-human clinical study, a step in the pathway to full FDA approval. Neuralink’s brain implant called the Link is intended to help patients with severe paralysis control external technologies using only neural signals. This means patients with severe degenerative diseases like ALS could regain their ability to communicate by moving cursors and typing with their minds. The Link is a type of brain-computer interface, or BCI, of which several are in development although none are yet approved.
Xacduro (sulbactam/durlobactam injection) for Pneumonia
The FDA has approved Xacduro (sulbactam for injection; durlobactam for injection) co-packaged for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of by Acinetobacter baumannii–calcoaceticus complex. Xacduro is a β-lactam–β-lactamase inhibitor. According to the manufacturer Innoviva Specialty Therapeutics, this approval makes Xacduro the first pathogen-targeted therapy approved to treat hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter. The approval was based on findings from the ATTACK phase 3 trial published earlier this month in Lancet Infectious diseases.
Brixadi (buprenorphine) for Opioid Use Disorder
Brixadi (buprenorphine) Extended-Release Subcutaneous Injection, a schedule III Controlled Substance, has received FDA approval for moderate to severe opioid use disorder. Brixadi is available in two formulations, a weekly and a monthly injection. Brixadi, a partial opioid agonist, is indicated for the treatment of moderate-to-severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. According to a press release from the manufacturer Braeburn Inc, BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Opvee (nalmefene) for opioid overdose
The FDA has approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. Nalmefene is an opioid receptor antagonist which is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation and low blood pressure. Drug overdose persists as a major public health issue in the United States, with more than 103,000 reported fatal overdoses occurring in the 12-month period ending in November 2022, primarily driven by synthetic opioids like illicit fentanyl. Opvee is manufactured by Opiant Pharmaceuticals Inc.
Brought to you by Nascentmc.com. A group of MD- and PhD-level medical writers serving the continuing medical education industry and meeting medical writing deadlines with excellence and enthusiasm.
Intro and outro music
Garden Of Love by Pk jazz Collective