FDA CDC News

FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

Published

10 months ago

November 10, 2023

Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.

The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.

The most common symptoms of chikungunya include fever and joint pain. Other symptoms may include a rash, headache, and muscle pain. Some individuals may experience debilitating joint pain that persists for months or even years. Treatment includes rest, fluids, and over-the-counter medications for pain and fever.

“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”

Ixchiq is administered as a single dose by injection into the muscle. It contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.

The safety of Ixchiq was evaluated in two clinical studies conducted in North America in which about 3,500 participants 18 years of age and older received a dose of the vaccine with one study including about 1,000 participants who received a placebo. The most commonly reported side effects by vaccine recipients were headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site.

In addition, although not commonly reported, severe chikungunya-like adverse reactions that prevented daily activity and/or required medical intervention occurred in 1.6% of Ixchiq recipients and none of the placebo recipients. Two recipients with severe chikungunya-like adverse reactions were hospitalized. In addition, some recipients had prolonged chikungunya-like adverse reactions that lasted for at least 30 days. The Prescribing Information includes a warning to inform that the vaccine may cause severe or prolonged chikungunya-like adverse reactions.

The FDA is requiring the company to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of Ixchiq.

Transmission of chikungunya virus to newborn babies from pregnant individuals with viremia (virus present in the blood) at delivery has been reported and can cause severe, potentially fatal chikungunya virus disease in newborns. In one study that evaluated whether the vaccine virus was present in the blood after vaccination, most individuals had vaccine virus detected in the blood within the first week following vaccination; the vaccine virus was not detected 14 days after vaccination. The Prescribing Information includes a warning to inform that it is not known if the vaccine virus can be transmitted from pregnant individuals to newborns, nor is it known if the vaccine virus can cause any adverse effects in the newborn. The warning also conveys that when considering administration to pregnant individuals, healthcare providers should take into consideration the individual’s risk of exposure to chikungunya virus, gestational age and risks to the fetus or neonate from disease caused by chikungunya virus in the pregnant individual.

The effectiveness of Ixchiq is based on immune response data from a clinical study conducted in the United States in individuals 18 years of age and older. In this study, the immune response of 266 participants who received the vaccine was compared to the immune response of 96 participants who received placebo. The level of antibody evaluated in study participants was based on a level shown to be protective in non-human primates that had received blood from people who had been vaccinated. Almost all vaccine study participants achieved this antibody level.

Ixchiq was approved using the Accelerated Approval pathway. Accelerated approval allows the FDA to approve certain products for serious or life-threatening conditions based on evidence of a product’s effectiveness that is reasonably likely to predict clinical benefit. In the FDA’s evaluation of Ixchiq for accelerated approval, evidence of effectiveness is based on immune response data in clinical trial participants. As a condition for approval for Ixchiq, the FDA is requiring confirmatory clinical studies to be conducted to verify clinical benefit.

Ixchiq was granted Fast Track and Breakthrough Therapy designations and the application was granted Priority Review. In addition, the FDA awarded the manufacturer of Ixchiq a tropical disease priority review voucher, under a provision included in the Food and Drug Administration Amendments Act of 2007. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.

The FDA granted approval of Ixchiq to Valneva Austria GmbH.

Related Information

Ixchiq (Chikungunya Vaccine, Live)

Author

Daily News Staff

View all posts

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

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.

Published

3 days ago

September 10, 2024

Hal Machina, Daily News Staff

selective focus photo of three eggs on tray — Photo by Monserrat Soldú on Pexels.com

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

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

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.

https://stmdailynews.com/category/stories-this-moment

Authors

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

News

FDA Approves Game-Changing Nasal Spray for Anaphylaxis Treatment

Published

2 weeks ago

August 30, 2024

Hal Machina

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

https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis?utm_medium=email&utm_source=govdelivery

https://stmdailynews.com/category/stories-this-moment

Author

Hal Machina

View all posts

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

health and wellness

Sun Pharmaceutical Announces FDA Approval of LEQSELVI™ for Severe Alopecia Areata

Published

4 weeks ago

August 20, 2024

Hal Machina, Daily News Staff

Sun Pharmaceutical Industries Limited is thrilled to announce that the U.S. Food and Drug Administration (FDA) has approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. This approval is a significant milestone, particularly for the roughly 300,000 Americans living with this challenging condition.

Alopecia areata is an autoimmune disorder marked by significant hair loss, often resulting in severe emotional and psychological distress. The journey to finding effective treatment options has been fraught with challenges, as the condition could be unpredictable and resistant to previous therapies.

Groundbreaking Clinical Trial Results

The FDA’s approval of LEQSELVI™ was supported by robust evidence from two Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which collectively enrolled 1,220 patients. These studies demonstrated that LEQSELVI™ delivered substantial hair regrowth: at 24 weeks, approximately one-third of the patients achieved 80% or more scalp hair coverage, a significant improvement from an average baseline scalp hair coverage of just 13%.

How LEQSELVI™ Works

LEQSELVI™ is a cutting-edge, twice-daily oral medication that selectively inhibits Janus Kinases (JAK) JAK1 and JAK2. This mechanism targets the immune pathways believed to contribute to the hair loss seen in severe alopecia areata, offering a new hope to those who have had limited success with existing treatments.

Safety and Efficacy

The treatment has been carefully tested for safety across several studies. While the medication is generally well-tolerated, it does carry warnings for serious infections, malignancies, thrombosis, and gastrointestinal perforations, similar to other treatments in its class. Patients and healthcare providers are advised to monitor for symptoms and manage them accordingly.

Support and Accessibility

Understanding the challenges associated with treatment access, Sun Pharma is initiating a comprehensive access program. This initiative will help eligible patients begin and adhere to their treatment, ensuring that LEQSELVI™ reaches those who need it the most. More details about this program are available on the official LEQSELVI™ website.

A Step Forward for the Alopecia Community

The approval of LEQSELVI™ represents a significant advancement for the alopecia community. Abhay Gandhi, CEO North America Business, Sun Pharma, shared his enthusiasm about bringing this innovative treatment to the market, stating it “offers a new and effective solution that will significantly enhance the options for patients and their physicians.”

Moreover, organizations such as the National Alopecia Areata Foundation (NAAF) have welcomed this new treatment option. Nicole Friedland, President and CEO of NAAF, highlighted the importance of this development, underscoring the profound impact alopecia areata can have on individuals’ lives.

Looking Ahead

With the introduction of LEQSELVI™, Sun Pharma continues to cement its position as a leader in dermatological treatments. The company’s commitment to addressing complex medical conditions through innovative solutions is evident in their rapidly expanding dermatology portfolio.

For patients suffering from severe alopecia areata, LEQSELVI™ represents not merely a new treatment option but a new hope—a possibility of regaining not just their hair, but also their confidence and quality of life.

For further details on LEQSELVI™ and patient support initiatives, visit www.LEQSELVI.com.

View the full multimedia release.

Disclaimer:
This content may include forward-looking statements, which are based on current expectations and projections about future events. Readers should not place undue reliance on these statements, as actual results may vary.