June 2, 2024: FDA new drugs roundup; Moderna RSV vaccine; metformin and aging study; adult ADHD meds and heart disease; cheaper version of GLP-1; voice problems and solutions; Zantac lawsuit
RSV Vaccine Approved
The U.S. Food and Drug Administration (FDA) approved Moderna's mRESVIA (Respiratory Syncytial Virus Vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) for patients age 60 and up. The vaccine's label indicates the shot was 79% effective at preventing at least two symptoms of RSV, such as cough and fever. RSV produces symptoms similar to a cold but can be fatal for young children and older adults. Moderna's RSV shot is the first messenger RNA-based (mRNA) vaccine not for COVID-19 to be approved in the United States.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-modernas-rsv-vaccine-its-second-marketed-product-2024-05-31/
Only two other RSV vaccines are available: GSK's Arexvy vaccine (approved in 2023 for patients age 60 and up) and
Pfizer's Abryvso RSV vaccine to prevent RSV in infants from birth to 6 months (approved in 2023 for pregnant individuals)
FDA Roundup of New Drug Approvals
The following new drugs were all announced in the May 31 FDA Roundup.
The FDA approved the first generic version of heart failure drug Entresto (sacubitril and valsartan). Heart failure happens when the heart cannot pump enough blood and oxygen to support other organs in the body. The Centers for Disease Control and Prevention (CDC) estimates that about 6.2 million adults in the United States have heart failure. The FDA says that Entresto tablets are a commonly used medication and are identified by the Centers for Medicare & Medicaid Services (CMS) as one of the costliest drugs under Medicare Part D. The generic version is made by Indian pharmaceutical company Alembic.
Patient reviews of Entresto on Ask a Patient website
The FDA approved pediatric indications for Loxo Oncology Eli Lilly's cancer drug: RETEVMO (selpercatinib). This is the first FDA approval of a targeted therapy for pediatric patients less than 12 years of age with certain kinds of metastatic thyroid cancer with RET mutations.
The FDA expanded its approval of Therapeutics' Breyanzi (lisocabtagene maraleucel), a CAR-T cell therapy for adult patients, to treat a rare blood cancer called mantle cell lymphoma (MCL). It is for patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi). This drug comes with a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of fatal or life-threatening CRS and neurological effects. The expanded approval for Bristol's drug is based on data from a study that showed it helped clear all signs of cancer in 67.6% of MCL patients who had previously received two or more treatments.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-allows-use-bristols-cell-therapy-rare-blood-cancer-2024-05-30/
Amgen's BKEMV (eculizumab-aeeb) was approved as an interchangeable biosimilar drug to Soliris (eculizumab) to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, and the treatment of patients with atypical hemolytic uremic syndrome (aHUS), a rare kidney disease that affects blood clotting. Bkemv, a monoclonal antibody, is the 53rd approved biosimilar in the U.S. The FDA has designated just 13 of them as interchangeable biosimilars.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-two-rare-diseases
Research News
A year ago, Ask a Patient News reported on a planned study, a 6-year trial enrolling 3,000 people between the ages of 65 and 79, that would examine how metformin could slow down aging. Research suggests metformin has anti-inflammatory effects that could help protect against common age-related diseases including heart disease, cancer, and cognitive decline. Alas, the required funding still has not materialized and so the research has not started. Dr. Barzilai, lead researcher from Albert Einstein College of Medicine, says "The main obstacle with funding this study is that metformin is a generic drug, so no pharmaceutical company is standing to make money," he says. NPR's Allison Aubrey interviewed a couple, both in their mid-60s, who take metformin and have noticed improvements in their health. Listen or read the transcript:
https://www.npr.org/sections/health-shots/2024/04/22/1245872510/a-cheap-drug-may-slow-down-aging-a-study-will-determine-if-it-works
Researchers at Copenhagen University Hospital found that adults (median age of 30) who start taking ADHD medications for the first time may be at higher risk of heart disease and stroke. The study was published in the Journal of the American College of Cardiology.
https://www.cbsnews.com/boston/news/adhd-medications-adulthood-heart-disease/
Read the research summary.
GLP-1 Drug News
A poll by KFF Health News suggests that one in eight adults have tried a GLP-1 drug (such as Ozempic, Mounjaro, or Wegovy). The share of adults who report ever taking these drugs is highest among people with diabetes (43%), followed by those with heart disease (26%) and those who have obesity or overweight (22%), the poll finds. Of those that took the GLP-1 drug, most (61%) used it to treat a chronic condition such as diabetes or heart disease – either alone (39%) or in combination with losing weight (23%). Nearly four in ten (38%) say that they took the drugs solely to lose weight.
https://www.kff.org/health-costs/press-release/poll-1-in-8-adults-say-theyve-taken-a-glp-1-drug-including-4-in-10-of-those-with-diabetes-and-1-in-4-of-those-with-heart-disease/
More about GLP-1 drugs and links to reviews at Ask a Patient:
https://www.askapatient.com/news/newly-approved-type-2-diabetes-drug-joins-GLP-1-class.asp
Patient demand for help with "Ozempic face" creates new market for dermatology drugs
Dermatologics maker Galderma would like to cash in on the market for patients seeking to reduce the gaunt face look that can result from use of GLP-1 weight loss and diabetes products. It is conducting a study to evaluate the effects of its Sculptra dermal filler and two types of Restylane "for cheek augmentation and contour deficiencies in GLP-1 patients."
https://www.yahoo.com/lifestyle/ozempic-face-could-create-huge-172014789.html
The American Society of Plastic Surgeons presents a list of the different types and brands of dermal fillers:
https://www.plasticsurgery.org/cosmetic-procedures/dermal-fillers/types
Compounded Version of GLP-1 drug, much cheaper
Hims & Hers Health, Inc. is launching an injectable weight loss drug with the same active ingredient (semaglutide) as diabetes and weight loss GLP-1 injectables Ozempic and Wegovy. The company announced that for $199 a month (85% cheaper than the brand name), customers can receive the Hims & Hers glucagon-like peptide-1 (GLP-1) injectable, unlimited virtual consultations and 24/7 access to a licensed medical provider. This is a compounded version of semaglutide, which means it is not approved by the U.S. Food and Drug Administration (FDA). However, as Forbes reports, "when drugs are listed on the FDA shortage list, some restrictions—like those preventing companies from compounding copies of previously approved drugs—are relaxed." Him & Hers says that it is partnering with an FDA-registered manufacturer for its 503B outsourcing facility, which is subject to state and federal oversight.
https://www.forbes.com/health/weight-loss/hims-hers-weight-loss-shots/
Lawsuit over Zantac Heartburn Drug
Multiple lawsuits that claim that Zantac over-the-counter heartburn treatment caused cancer have resulted in millions of dollars in settlements to patients. In the latest Zantac-related development, Valisure, the Connecticut-based quality assurance lab that first raised concerns about Zantac in 2019, accuses GSK of a decades-long cover-up. Valisure filed a 212-page complaint that alleges the GSK's product contained cancer-causing NDMA since the 1970s. Valisure, on behalf of taxpayers, seeks what could amount to billions of dollars to recoup from alleged false reimbursements on the drug. The drug, including all versions of ranitidine, has been removed from the market since April 2020 (scroll to bottom of the AskaPatient article on heartburn drugs to see list of products and explanation of the ranitidine recall).
https://www.drugwatch.com/news/2024/05/30/pfizer-settles-10000-zantac-lawsuits-for-up-to-250-million/
Medication Tips: Drugs that Might Affect the Voice
Recently, singer Bruce Springsteen had to cancel some his scheduled European show dates because of vocal chord issues. There are many reasons the voice can become impaired, but did you know that drug side effects can be one of the reasons? MedShadow's Melissa Finney reviews categories of drugs, including antihistamines, decongestants diuretics, hormones, and more, that may affect your voice.
https://medshadow.org/springsteen-cancels-european-show-dates-citing-vocal-issues/
Professional opera singer David Aaron Katz provides a list of herbs he has used throughout his career to help heal and soothe his vocal chords. Katz is also a nutrition consultant, herbalist, and head of the vocal faculty for the Bronx Defenders Training Academy. Includes a recipe for making a gargle with the herbs.
https://chorusamerica.org/singers/natural-vocal-care
Just for Fun: Medical Word Game
Is one game per day of the New York Times Wordle not enough for you? Medical website Healio has its own health-themed Wordle-style game called "Word Doc." The rules are the same (figure out a 5-letter word within 6 turns of guessing), but you have an extra clue: the answer is a medical-related term. Because the website caters to doctors and other health care professionals, some of the words are esoteric. (Today's is not too easy, but if you don't get it, a definition is provided.) Others are very easy: recent word solutions include "stage," "covid," "group," and "blind." Try it out at
https://www.healio.com/worddoc
Note to readers: The first June drug safety update of the month will be posted tomorrow, June 3.
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