February 18, 2024: New drugs for food allergy, melanoma, frostbite, acetaminophen overdose; new pharma ads rules; reducing cancer drug side effects; preventing "senior moments;"and more
New Drug Approvals
The Food & Drug Administration (FDA) approved asthma drug Xolair (omalizumab) as a treatment to reduce the risk of anaphylactic reactions in people with severe food allergies after accidental exposure to allergy-causing foods. Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-help-reduce-allergic-reactions-multiple-foods-after-accidental
Xolair Drug Label
Xolair reviews at Ask a Patient website
The FDA approved Iovance Biotherapeutics' Amtagvi (lifileucel), a T-cell immunotherapy, for adult patients with metastatic melanoma after other treatments have failed. This is first FDA-approved one-dose cell therapy for a solid tumor and the first tumor-infiltrating lymphocyte (TIL) therapy. Fierce Pharma reports that in a single-arm study, Amtagvi shrank tumors in 31.5% of 73 patients in the study and after 18.6 months of follow-up, 43.5% of responders had been in remission for more than a year.
An advantage of the TIL therapy is that the cancer-fighting T-cells are not genetically modified, but the patient's own T-cells (extracted from the tumor) are replicated in the lab. Like other cell-based treatments, chemotherapy is required beforehand, and the patient must be healthy enough to wait up to eight weeks while the custom treatment is made. Iovance set the wholesale acquisition cost to be $515,000 per patient.
https://www.fiercepharma.com/pharma/fda-approves-iovances-amtagvi-first-cell-therapy-solid-tumor
This video from Melanoma Research Foundation explains how TIL cell therapy works for treating melanoma:
Read more about the TILs technology:
https://blog.dana-farber.org/insight/2021/04/what-are-tils-and-how-are-they-used-in-cancer-treatment/
https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy
The FDA approved Eicos Sciences' Aurlumyn (iloprost) injection, the first medication to treat severe frostbite in adults to reduce the risk of finger or toe amputation. The FDA says that "frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation. Iloprost, the active ingredient in Aurlumyn, is a vasodilator (a drug that opens blood vessels) and prevents blood from clotting." Iloprost was originally approved in 2004 (Ventavis brand name) for the treatment of pulmonary arterial hypertension. Aurlumyn is administered by continuous I.V. infusion for six hours a day for up to a maximum of eight consecutive days.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-treat-severe-frostbite
The FDA approved Galephar's Legubeti, a new formulation of acetylcysteine, an antidote to prevent liver injury that may occur following an overdose of acetaminophen in adults and pediatric patients. This unusual product formulation consists of packets of powder that are to be mixed with caffeine-free diet cola or other diet soft drink, based on patient weight. All other currently available formulations of acetylcysteine used for acetaminophen overdose are solutions administered intravenously. It is essential to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of acetaminophen ingestion.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215040s000lbl.pdf
TV Ads for Prescription Drugs to Change this Year
In coming months, light-hearted television ads for prescription drugs are likely to become less upbeat but more informative, as the FDA has implemented a new rule, effective May 20, 2024, setting new format regulations that direct-to-consumer prescription drug advertisers must adhere to by November 20, 2024. The ads must include a "major statement," which discloses the product’s major adverse effects and contraindications in a manner that is understandable. In particular, these five standards must be followed:
Information must be presented in consumer-friendly language;
The Major Statement’s audio information is at least as understandable as the audio information in the overall ad;
No visual or auditory interference may occur during the presentation of the Major Statement.
Additionally, for television ads,The Major Statement’s audio information presented concurrently in text; and
The text information must be formatted in an easy-to-read manner.
Currently, audio information does NOT have to be presented with the same information in text; in fact, usually there is a distracting video playing concurrently that makes it easy for the audience to not pay attention to the message about side effects.
Public Citizen's Health Research Group says that if drug manufacturers seek to push the boundaries of the standards, the FDA must be willing to push back with prompt enforcement actions. They also say that the agency should conduct or fund research to assess the effects of the final rule on the quality of the advertisements.
https://www.worstpills.org/newsletters/view/1580 (article is paywalled; abstract is available)
Aurobindo’s Eugia Facility Temporarily Stops Production after FDA Inspection
Earlier this month, the FDA concluded its inspection of generics maker Aurobindo Pharma's Eugia Pharma Specialties manufacturing facility in Telangana, India, and found some problems with manufacturing quality and documentation. It sent the company a 26-page copy of its findings (Form 483) describing nine "observations."
As a precautionary measure, Aurobindo has temporarily stopped manufacturing operations of certain product lines (injectable "aseptic" types of drugs were of particular concern) at the facility, which makes up over half of their pending pipeline to the U.S. market. Deccan Herald reports that while the U.S. has tried to strengthen its relationships with the Indian pharmaceutical industry in order to lessen its reliance on China for generics, in reality, even India's generics makers rely heavily on China as source for active pharmaceutical ingredients.
https://www.deccanherald.com/business/us-leans-on-indias-pharma-industry-to-snub-china-theres-just-one-catch-2881475
Patients Need Less Cancer Drug Side Effects
Cancer patients and doctors are advocating for a change in how new cancer drugs are tested and prescribed to reduce the debilitating side effects that many experience while undergoing treatment. Jill Feldman, a 54-year old lung cancer patient from Deerfield, Illinois, explains the harsh side effects she has experienced over 15 years of treatments. She has lowered her dose with her doctor’s blessing but wants drug makers to study lower doses early in the research process. Feldman explains that there needs to be a paradigm shift from maximum tolerable dose to the minimum effective dose so that a cancer patient can maintain a quality of life. Through a program called Project Optimus, the FDA is pushing drug makers to include more patients in early dose-finding trials to get better data on when lower doses can work. A.P. News' Carla K. Johnson reported this story.
https://apnews.com/article/cancer-treatment-drugs-doses-lung-breast-495855360fdd6f213990c781c82690ea
(Video of interview with Jill Feldman)
Research News
In a new study of nasal decongestant purchasing patterns, researchers at the University of Pittsburgh School of Medicine found that phenylephrine remained the most popular choice year after year, despite decades of concerns over a lack of evidence supporting its effectiveness. A research letter points to a coming wave of supply-chain disturbances if the Food and Drug Administration (FDA) moves to pull oral phenylephrine from the shelves, as recommended by an FDA advisory panel in 2023 that found the medication ineffective. The research letter was published in JAMA.
https://www.upmc.com/media/news/020824-decongestant-from-market
Read our related post on the phenylephrine debacle from September 2023:
University of Queensland researchers say that exercise can be a powerful tool to fight depression and should be routinely prescribed as part of treatment plans. Dr Michael Noetel from UQ’s School of Psychology reached this conclusion after reviewing more than 200 studies looking at the effect of exercise, psychotherapy and antidepressants in treating depression. The study was published in BMJ.
https://www.uq.edu.au/news/article/2024/02/exercising-your-way-out-of-depression
Healthy Aging Tips – Body and Brain
Over a lifetime, your body changes in ways that affect how well it responds to medications. MedShadow Foundation’s Melissa Finney reports that the medical industry has determined that enough change has occurred by age 65 to warrant unique “rules of thumb,” or health treatments protocols for patients age 65 and older. Check out Finney's discussion of how aging affects the body and why certain drugs may be of particular concern (should be taken at lower doses or not at all) as you get older.
https://medshadow.org/so-you-are-65-now-what-medications-all-seniors-should-know-not-to-take/
Aging Matters' host Cheryl Beversdorf interviewed Stan Goldberg, Ph.D., professor emeritus at San Francisco State University and author of a recently published book "Preventing Senior Moments: How to Stay Alert into Your 90s and Beyond." They discuss myths, causes, types, and prevention strategies for "senior moments" as well as the differences between senior moments and dementia symptoms. 78-year old Goldberg shares examples of his own and others' senior moments that illustrate how such events can be grouped into types – all of which result from an information processing error, but not necessarily a loss of memory.
Goldberg suggests practicing specific behavior strategies to help your brain function more effectively as you age. Such practice can help even if you are diagnosed with dementia in the future. Strategies include: learning new patterns, combatting inertia, challenging your brain, and more. The interview closes with this message from Goldberg (paraphrased): As we age, we have three choices: 1) we can accept aging as something inevitable and despicable 2) we can pretend we're not getting old 3)(the option he chooses): we can function adequately and joyfully if we're willing to do compensatory strategies. This podcast is 49 minutes long.
Goldberg is a frequent contributor to Psychology Today. (Link goes to list of his articles and books.)
Please visit us at AskaPatient.com for patient reviews and ratings of prescription drugs and some vaccines.
If you like this newsletter, please send the link (askapatientnews.substack.com) by email or text to someone who also might enjoy it!
Thank you for supporting Ask a Patient® Health News: Drugs & Treatments.