April 7, 2024: Covid-19 prophylactic, new antibiotic, Nexletol nod for cardiovascular disease, ALS drug gone; good news for Eliquis; two cancer patients share story; keto diet
The U.S. Food and Drug Administration (FDA) approved Invivyd’s monoclonal antibody drug Pemgarda under an Emergency Use Authorization (EUA) for prevention of Covid-19 in high-risk (moderate to severely immune-compromised) patients who have not had a known recent exposure to Covid-19. The drug is administered by intravenous infusion for at least 60 minutes. It may be repeated every 3 months as needed.
https://www.2news.com/news/fda-approves-covid-prevention-drug-for-emergency-use/video_b11100be-297f-5d35-9b8f-4c83f905450a.html
Pemgarda’s authorization was based on a clinical trial in which 623 participants received at least one dose of Pemgarda. Some participants received a second dose of either Pemgarda 4500 mg or placebo at month 3. The FDA does not provide data on how many participants became ill with Covid-19. To support this EUA, an "immunobridging approach" was used to determine if Pemgarda may be effective for pre-exposure prophylaxis of COVID-19. The FDA concluded that "based on the totality of scientific evidence available, it is reasonable to believe that Pemgarda may be effective for pre-exposure prophylaxis of COVID-19 in the authorized population. They also point out limitations of the data supporting the benefits of Pemgarda.
https://www.fda.gov/media/177068/download?attachment
New Antibiotic for Three Different Uses
The FDA approved Basilea's Zevtera (ceftobiprole medocaril sodium for injection) for three types of infections: 1)the treatment of adults with Staphylococcus aureus bloodstream infections (SAB) (this includes the common MRSA infections experienced by hospital patients); 2) adults with acute bacterial skin and skin structure infections (ABSSSI); and 3) adult and pediatric patients three months old and up with community-acquired bacterial pneumonia (CABP).
http://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses
Fierce Pharma reports that fifteen years ago, ceftobiprole was rejected by the FDA, but over the years it has gained approval in more than 80 countries—including China, Canada, Brazil and most of Europe to treat a variety of infections. But until now, "the U.S. has been a stubborn holdout."
https://www.fiercepharma.com/pharma/basilea-completes-marathon-quest-fda-approval-treat-3-types-infections
PAH Drug Approved
The FDA approved Merck's Winrevair (sotatercept-csrk) for the treatment of a serious and progressive high blood pressure condition called pulmonary arterial hypertension (PAH).
https://www.fiercepharma.com/pharma/merck-walks-away-key-fda-approval-pah-drug-winrevair
Drug label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761363s000lbl.pdf
Expanded Use Granted for Vemlity, Nexletol and Fanapt
Gilead's Hepatitis B drug Vemlity (tenofovir alafenamide) approval was expanded to include use by children age 6 and up and the label was updated to include clinical data supporting the pediatric use. “Chronic hepatitis B can have a significant and lasting impact on the health of children,” Chaun-Hao Lin, MD, associate professor of clinical pediatrics at Krek School of Medicine of USC, said in a Gilead press release. “If left untreated, hepatitis B can lead to liver cirrhosis and liver cancer.
https://www.healio.com/news/gastroenterology/20240328/fda-extends-vemlidy-approval-for-chronic-hepatitis-b-to-children-as-young-as-6-years
Esperion's cholesterol drugs Nexletol (Bempedoic acid) and Nexlizet (Bempedoic acid/ezetimibe) were approved for cardiovascular risk reduction in adults who are unable to take recommended statin therapy with established cardiovascular disease (CVD), or a high risk for a CVD event but without established CVD. Supporting trials showed Bempedoic acid reduced risk for a composite of major adverse CV events, including CV death, nonfatal stroke, nonfatal MI and coronary revascularization, compared with placebo.
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211616Orig1s012;%20s013ltr.pdf
Vanda Pharmaceutical's schizophrenia drug Fanapt (iliperidone) is now also approved to treat bipolar 1 disorder. The label had extensive safetly label update.
https://www.ajmc.com/view/fda-approves-iloperidone-for-adults-with-bipolar-1-disorder
Good News for Eliquis
Consumer watchdog group Public Citizen upgraded its recommendation for blood thinner drug Eliquis (apixaban) from a "Do not Use" designation to "Limited Use." Apixaban was first approved by the FDA in 2012 to decrease the risk of stroke and systemic embolism (a blood clot lodged inside a blood vessel) in patients with atrial fibrillation not caused by a heart valve problem. Several older anticoagulants, such as warfarin and injectable heparins (such as enoxaparin and Lovenox) are well-studied and for many years have been standard treatments for patients who are at risk of blood clots not caused by a heart valve problem. Based on more recent evidence, Public Citizen reassessed the risk–benefit balance of apixaban and changed its designation.
https://www.worstpills.org/newsletters/view/1589 (article is paywalled; abstract available)
ALS drug Relyvrio, deemed ineffective, removed from the market
Amylx's drug for ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease) Relyvrio (sodium phenylbutyrate–taurursodiol ) has been withdrawn from the market as of April 4. However, patients currently on the drug in the United States and Canada who, in consultation with their physician, want to remain on treatment can be transitioned to a free drug program. The drug was approved in September 2022 with a stipulation that clinical trial results support its effectiveness. Relyvrio failed to meet any of the trial's goals: it did not improve patients' physical functions, which were scored on a standardized ALS-specific test, nor did it improve quality of life, respiratory function, or overall survival.
https://www.medscape.com/viewarticle/amylyx-ditches-controversial-als-drug-relyvrio-2024a10006g2
The failure of the drug "puts a spotlight" on controversial FDA approvals.
https://www.washingtonpost.com/business/2024/03/16/als-drug-relyvrio-fda/
Study Finds Paxlovid Does Not Shorten Symptom Duration for Vaccinated Patients
A new study conducted by a Pfizer research group suggests that, for those fully vaccinated against COVID-19 and having at least one risk factor for severe COVID, Pfizer's antiviral drug Paxlovid did little to reduce symptom duration. The phase 2/3 trial of 1,296 participants randomly assigned in a 1:1 ratio to receive nirmatrelvir–ritonavir (Paxlovid) or placebo every 12 hours for 5 days within 5 days of COVID-19 symptom onset. A total of 654 participants took Paxlovid, and 634 participants took the placebo. Experts caution the findings might not apply to older patients as the median age of trial participants was 42. The research was published in The New England Journal of Medicine.
https://www.medpagetoday.com/infectiousdisease/covid19/109486
Also: https://www.cidrap.umn.edu/covid-19/among-fully-vaccinated-study-shows-paxlovid-does-not-shorten-symptoms
Read or add reviews for Paxlovid at Ask a Patient
Two Cancer Patients’ Stories
After being diagnosed with stage 4 lung cancer in 2020, writer Annabelle Gurwitch became depressed and overwhelmed with anxiety, finding it difficult to write and tackle other everyday tasks. She decided to try eskatamine, a psychedelic drug that has worked wonders for some patients, lifting depression symptoms after just a small number of in-office treatments. Gurwitch kept a "ketamine diary" of her experiences at each of the six sessions at the therapy clinic. Like many treatments, results can vary; for her, it wasn't the "brain tuneup" she had hoped for. Check out "What does ketamine feel like? I kept a diary."
https://www.washingtonpost.com/wellness/2024/03/23/what-does-ketamine-feel-like/
Last month, actor William Shatner shared his stage-four melanoma story with attendees of the American Academy of Dermatology Annual Meeting. He credited a successful immunotherapy regimen with saving his life. At age 93 years, he is now cancer-free, he said. Shatner recalled “the care and love a doctor can give a patient in that moment.”
https://www.healio.com/news/dermatology/20240311/after-stage-4-melanoma-diagnosis-treatment-william-shatner-shares-new-outlook-on-life
Parkinson’s and GLP-1 Drug Study
Researchers in France found that over the course of a year, early stage Parkinson's patients given a daily dose of lixisenatide (a diabetes GLP-1 med in the same drug class as Ozempic), showed essentially no progression of motor problems, while those given the placebo showed worsening symptoms, dropping around three points on the 132-point assessment scale – a modest difference, yet thought to be clinically meaningful. Both sets of patients (of 156 total) also took their usual Parkinson's medication. The study was published in the New England Journal of Medicine.
https://www.theguardian.com/society/2024/apr/03/diabetes-drug-may-slow-progression-of-parkinsons-say-researchers
"There’s been no shortage of buzz about the GLP-1 family of drugs, but that was amplified in many ways this week.” Listen to Ground Truths’ cardiologist and author Eric Topol interview Daniel Drucker, the physician-scientist credited as one of the co-discovers of glucagon-like peptide (GLP-1) nearly 3 decades ago. (Transcript also available at this link.)
Food as Medicine
A small pilot study by Stanford Medicine showed that the metabolic effects of a ketogenic diet improved severe mental illness. As Shebani Sethi, MD, study author and associate professor of psychiatry and behavioral sciences explains," its very promising and very encouraging that you can take back control of your illness in some way, aside from the usual standard of care.” The study was published in Psychiatry Research.
https://med.stanford.edu/news/all-news/2024/04/keto-diet-mental-illness.html
Check out this short video interview with Dr. Sethi.
Medication Tips: Magnesium for Migraines
Some people find relief from migraines with a simple supplement: magnesium. Magnesium oxide is the most commonly used form for migraine treatment, with a recommended daily dosage of 400 to 500 milligrams. Find out why magnesium can help with migraines, and why some people also take riboflavin to boost its effects. Also find links to additional Discover Magazine articles on what you should know about magnesium supplements and on the science of migraines.
https://www.discovermagazine.com/health/magnesium-could-help-manage-horrible-headaches-like-migraines
Considering a Full-Body MRI?
Last week, a reader asked Dr. Lucy McBride:
"Are full body MRIs a good idea? For health screening? I have seen a bunch of celebrities promoting them - but are they just trying to make more money? -Carson P."
Dr. McBride’s Answer: “Great question. I hope someday we have evidence-backed, cost-effective imaging technology to assess the structure and function of our major organ systems. But right now, I don’t think full-body screening MRIs are ready for primetime….” Check here for her complete answer:
https://lucymcbride.substack.com/i/143284412/question-full-body-mris
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