FDA CDC News
FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases
Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications:
Adult patients with:
- moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
- active psoriatic arthritis;
- moderately to severely active Crohn’s disease; and
- moderately to severely active ulcerative colitis.
Pediatric patients 6 years of age and older with:
- moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
- active psoriatic arthritis.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, M.D., director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”
Biological products include medications for treating many serious illnesses and chronic health conditions. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). An interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs.
All biological products are approved only after they meet the FDA’s rigorous approval standards. This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product. Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine.
“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. “This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”
The FDA’s approval of Wezlana is based on a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness). This evidence included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.
Like Stelara, the most serious known side effect of Wezlana is infection. The most common adverse reactions with ustekinumab products are nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever and diarrhea.
The labeling for Wezlana, like Stelara, contains a warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization. There is also a warning that some malignancies, hypersensitivity reactions, and cases of Posterior Reversible Encephalopathy Syndrome have been reported in patients who received Wezlana in clinical studies. Wezlana must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
The FDA granted the approval of Wezlana to Amgen, Inc.
Related Information
- Information on Biosimilars for Patients and Health Care Providers
- Prescribing Biosimilars and Interchangeable Biosimilars
- Purple Book Database of Licensed Biological Products
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Lifestyle
Mac and Cheese Recall: Potential Spoilage Concerns Affect Products at Major Retailers
Mac and Cheese Recall
In a recent announcement by the Food and Drug Administration (FDA), two types of macaroni and cheese products sold at major retailers have been recalled due to concerns over potential spoilage. The recall affects Reser’s American Classics Macaroni & Cheese and Reser’s American Classics Macaroni & Cheese White Cheddar, as part of a broader recall of Reser’s Fine Foods deli salads and refrigerated items.
Scope of the Recall
The affected macaroni and cheese varieties were distributed across five states: California, Illinois, Minnesota, North Dakota, and South Dakota. The specific “use by” dates for the recalled products are as follows:
- Reser’s American Classics Macaroni & Cheese: Use by dates of September 14 and September 16, 2024.
- Reser’s American Classics Macaroni & Cheese White Cheddar: Use by date of September 11, 2024.
In addition to the macaroni and cheese products, the recall includes a variety of other items such as potato salad, scalloped potatoes, pasta salad, corn, egg salad, spinach dip, gravy, and various desserts.
Cause of the Recall
According to the FDA, the potential spoilage was linked to “temperature abuse” during transportation, specifically due to a malfunctioning refrigeration unit on a trailer. A representative from Reser’s Fine Foods confirmed to FOX Business that the issue was isolated to a single truckload of product delivered to only one distributor location.
“The recall was initiated on July 29, 2024, and no affected products ever made it to the store shelves,” the representative stated. They further reassured consumers that any items purchased from stores are safe to consume.
Retailer Responses
Major retailers, including Safeway, Stop & Shop, and Walmart, which stock Reser’s macaroni and cheese products, have stated that their stores were not impacted by the recall. However, Target, another retailer selling the products, did not provide a comment when contacted by FOX Business.
Consumer Safety First
The FDA and Reser’s Fine Foods have stressed the importance of consumer safety in this situation. While the affected products have not reached store shelves, customers who may have purchased any items from the recalled batch are encouraged to check the packaging for the specified “use by” dates.
As always, consumers are advised to be vigilant about food safety and to report any concerns to their local health department or the FDA. For those who may have questions or require further information regarding this recall, contacting Reser’s Fine Foods directly or checking the FDA’s website can provide additional clarity.
In conclusion, while the recent recall raises concerns over food safety, companies and regulatory agencies are working diligently to ensure that consumers remain informed and protected. As the situation develops, staying updated through reliable sources is essential for maintaining food safety standards in your household.
Read the story on Fox Business.com: https://www.foxbusiness.com/lifestyle/mac-cheese-sold-major-retailers-recalled-potential-spoiling
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FDA CDC News
Important Recall Alert: Milo’s Poultry Farms and Tony’s Fresh Market Eggs Potentially Contaminated with Salmonella
Milo’s Poultry Farms, LLC has recalled eggs under the “Milo’s Poultry Farms” and “Tony’s Fresh Market” labels in Wisconsin, Illinois, and Michigan due to Salmonella contamination, advising consumers to discard or return products.
As of September 6, 2024, Milo’s Poultry Farms, LLC, headquartered in Bonduel, Wisconsin, has issued a voluntary recall of all its egg products due to possible contamination with Salmonella. This recall applies to both “Milo’s Poultry Farms” and “Tony’s Fresh Market” branded eggs, spanning across various retail stores and foodservice distributors in Wisconsin, Illinois, and Michigan.
What You Need to Know
Salmonella is a bacteria that can cause serious and occasionally fatal infections, particularly in young children, the elderly, and individuals with weakened immune systems. Healthy individuals infected with Salmonella often experience fever, diarrhea (potentially bloody), nausea, vomiting, and abdominal pain. In severe cases, the infection can result in the bacteria entering the bloodstream and causing more critical conditions such as infected aneurysms, endocarditis, and arthritis.
Scope of the Recall
The recall encompasses:
- All carton sizes and types of eggs under the “Milo’s Poultry Farms” label, across all expiration dates.
- All carton sizes of “Tony’s Fresh Market” branded eggs, applicable to all expiration dates.
- All cases of eggs intended for retail foodservice distribution, regardless of expiration dates.
Reason for the Recall
The recall was triggered after environmental samples collected by the FDA tested positive for Salmonella. Further investigations through whole genome sequencing linked these samples to an ongoing outbreak of Salmonella, prompting immediate action by Milo’s Poultry Farms.
Consumer Safety Measures
Milo’s Poultry Farms, LLC has temporarily halted production and distribution of the affected products to conduct necessary testing and sanitization processes at their facilities.
What Should Consumers Do?
Customers who have purchased any of the recalled eggs are strongly advised not to consume them. These products should be discarded immediately or returned to the place of purchase for a full refund.
Consumers with additional questions or concerns can reach out directly to Milo’s Poultry Farms, LLC at (715) 758-6709 for further guidance and support.
Stay Informed
Salmonella is an ongoing risk in uncooked poultry and eggs. Consumers are reminded to cook eggs thoroughly before consumption to kill bacteria and prevent illness. Stay updated with food recall alerts and safety guidelines to ensure the health and safety of you and your family.
Remember, food safety is paramount. Keep abreast of the latest FDA warnings and manufacturer recalls to safely navigate any potential health risks associated with contaminated products.
About the FDA
The Food and Drug Administration (FDA) is a U.S. federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA also regulates the nation’s food supply to safeguard against contamination and prevent foodborne illnesses. One of its key functions is monitoring and managing food recalls when potential risks are identified, ensuring that hazardous foods are quickly and effectively removed from the market. The FDA issues alerts to inform the public about foodborne illness outbreaks, working collaboratively with manufacturers to recall affected products and maintain the safety and integrity of the food supply chain.
Follow FDA
- Follow@US_FDA on X
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- Follow@FDArecallson X
- Recent Recalled Product Photos on FDA’s Flickr Photostream
Read the FDA release here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/milos-poultry-farms-llc-recalls-eggs-because-possible-health-risk
Source: FDA
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STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.
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News
FDA Approves Game-Changing Nasal Spray for Anaphylaxis Treatment
In a landmark decision on August 9, 2024, the U.S. Food and Drug Administration (FDA) approved the first-ever nasal spray, neffy, for the emergency treatment of severe allergic reactions, including anaphylaxis, in individuals weighing at least 30 kilograms (approximately 66 pounds). This approval marks a significant breakthrough in the management of life-threatening allergic reactions, offering a non-injectable form of epinephrine that could transform how patients handle emergency situations.
Breaking Away from Injections: The Significance of Neffy
Traditionally, the treatment of anaphylaxis—a rapid and severe allergic reaction—has relied solely on injectable forms of epinephrine. This method, while effective, poses a challenge for many, particularly children who might fear needles, potentially delaying life-saving intervention. Neffy emerges as an innovative solution, providing epinephrine in a nasal spray form. As highlighted by Dr. Kelly Stone, MD, PhD, of the FDA’s Center for Drug Evaluation and Research, the development of neffy addresses an urgent need by removing the barrier of injection-associated anxiety and facilitating quicker, more accessible treatment.
The Science Behind Neffy
The approval of neffy was based on extensive clinical research involving 175 healthy adults. These studies explored the absorption and effect of neffy compared to traditional injectable epinephrine forms, focusing on indicators such as epinephrine concentration in the blood and the consequent physiological responses like changes in blood pressure and heart rate. The results confirmed that neffy delivers comparable epinephrine levels and physiological effects necessary for treating anaphylaxis effectively. Further research in children over 66 pounds mirrored these findings, showcasing neffy’s efficacy across different age groups.
How Neffy Works
Neffy is administered as a single dose via a nasal spray into one nostril. In cases where symptoms do not improve or worsen, a second dose may be applied using a new unit. It’s imperative for users to seek immediate medical attention after administering neffy to ensure comprehensive care and monitoring.
Considerations and Side Effects
While neffy stands as a revolutionary step forward, it comes with necessary precautions. Individuals with certain nasal conditions, such as nasal polyps or a history of nasal surgeries, may experience altered absorption rates. In such cases, traditional injectable products might be recommended. Users must also be cautious about potential side effects, which can include throat irritation, headache, nasal discomfort, and dizziness among others.
A Forward Leap in Allergy Management
With the introduction of neffy, patients and caregivers now have a less invasive option at their disposal. This development not only expands the tools available for combating severe allergic reactions but also significantly lowers the threshold for timely, effective intervention. The FDA’s fast-track designation of neffy underscores its potential impact, promising a new era of empowerment for those living with severe allergies.
In conclusion, the FDA’s approval of neffy represents a major advance in allergy care, highlighting ongoing innovation in medical treatments and patient care options. As neffy becomes available, it is poised to become a crucial asset in allergy management, enhancing safety and comfort for patients across the United States.
Source: FDA
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.
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