Breaking News
February 24, 2018 - New CSIRO technology can create clean drinking water
February 24, 2018 - Treating sleep-disordered breathing may improve prognosis of heart failure patients
February 24, 2018 - Early life exposure to green space could have beneficial effects on cognitive function
February 24, 2018 - Joint Surgery: Aspirin Equals NOAC for Post-Acute VTE Prevention
February 23, 2018 - Scientists identify new marker of arthritis in mice
February 23, 2018 - Beetroot juice supplements may benefit patients with heart failure
February 23, 2018 - New study identifies novel molecular biomarkers of preeclampsia
February 23, 2018 - Researchers discover new link between gut bacteria and obesity
February 23, 2018 - Aimmune Therapeutics’ Pivotal Phase 3 PALISADE Trial of AR101 Meets Primary Endpoint in Patients With Peanut Allergy
February 23, 2018 - Improving Glaucoma Care: Ophthalmology Times
February 23, 2018 - Preventing dementia: The promising, the disappointing and the inconclusive
February 23, 2018 - Duke researchers show how to retrain immune system of peanut-allergy mice
February 23, 2018 - Older males could live longer with light intensity exercise, study suggests
February 23, 2018 - C-sections and gut bacteria linked to childhood obesity risk
February 23, 2018 - Asthmatics have lower degree of DNA methylation in certain immune cells
February 23, 2018 - Uniforms coated with copper nanoparticles could reduce spread of hospital infections
February 23, 2018 - What Not to Do If You Have Asthma and Want to Get Pregnant
February 23, 2018 - Deep brain stimulation may be promising Alzheimer’s treatment
February 23, 2018 - AMSBIO offers new PARPtrap Assay Kit
February 23, 2018 - New study identifies mechanisms to lengthen egg viability in worms
February 23, 2018 - Interventions to improve self-concept could be critical in treating mental health patients
February 23, 2018 - Few minutes of physical activity may lower risk of death in older men, research suggests
February 23, 2018 - Modifications in HIV test enable rapid detection of Zika virus, study states
February 23, 2018 - Could Hackers Target Heart Devices?
February 23, 2018 - Kids’ Mental Health Status Not a Factor in Gun Storage
February 23, 2018 - Revellers ready for festival drug checks, study finds
February 23, 2018 - Stanford researchers explore how enzyme changes and becomes antibiotic-resistant
February 23, 2018 - Scientists decode molecular structure of healthy huntingtin protein
February 23, 2018 - Efficacy of cancer immunotherapy increased by deactivating tumor defence mechanism
February 23, 2018 - Epigenetic changes due to normal aging process linked to cancer risk
February 23, 2018 - Evaluations of Medicaid experiments by states, CMS are weak, GAO says
February 23, 2018 - Biomarkers ID’d for Anesthesia-Related Neural Damage
February 23, 2018 - Study reveals how kidney disease happens
February 23, 2018 - Iron deficiency early in life can have long-lasting consequences for the brain
February 23, 2018 - High protein diet reduces risk of Alzheimer’s disease, research finds
February 23, 2018 - Research extends powerful capabilities of MRI to nanometer scale
February 23, 2018 - Scientists show that cutting-edge technique can efficiently sort nano-sized particles
February 23, 2018 - Dornier’s new laser innovation delivers confidence to glide through deflected scopes
February 23, 2018 - Neurocrine Biosciences Will File New Drug Application for Opicapone for Parkinson’s Disease Based on Existing Pivotal Clinical Trial Data
February 23, 2018 - Bariatric Surgery Enabled Stopping Diabetes Meds
February 23, 2018 - C-sections and gut bacteria increase risk of childhood obesity
February 23, 2018 - Busting myths about diet and kidney stones
February 23, 2018 - Reformulating vaccines to prevent relapse
February 23, 2018 - Prophylactic use of haloperidol does not reduce delirium burden
February 23, 2018 - Higher prevalence of kidney stones in Southern United States
February 23, 2018 - Lithotripsy has revolutionized modern kidney stone management
February 23, 2018 - Researchers describe important step toward gene therapy for patients with Sandhoff disease
February 23, 2018 - Pain Therapeutics Resubmits New Drug Application for Remoxy ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain
February 23, 2018 - Combo Therapy Highly Active in Untreated RCC
February 23, 2018 - Boosting a key protein to help bones that won’t heal
February 23, 2018 - Advanced method holds promise for substantial improvements in breast cancer diagnosis
February 23, 2018 - MRI and machine learning could predict whether OCD patients will benefit from treatment
February 23, 2018 - Comparing low-fat and low-carb diets finds little difference
February 23, 2018 - FDA Alert: Clarithromycin (Biaxin): Drug Safety Communication
February 23, 2018 - Out of Limbo Into Bomb Scare
February 23, 2018 - Patients who achieve short-term weight loss before bariatric surgery have better outcomes
February 23, 2018 - Beetroot may reduce kidney failure risk after heart x-ray, research reveals
February 23, 2018 - Sleep disruptions in menopause correlated with hot flashes and depression
February 23, 2018 - Scientists discover new treatment approach to curb severe myocarditis
February 23, 2018 - ‘Click chemistry’ approach may improve disease-fighting properties of drugs
February 23, 2018 - NIGHTSEA and EMS team up to offer KEY Award in fluorescence stereo microscopy
February 23, 2018 - Calorie restriction improves intestinal-tissue regeneration after injury
February 23, 2018 - Tobacco Kills, No Matter How It’s Smoked: Study
February 23, 2018 - Q&A: Avindra Nath, MD | Medpage Today
February 23, 2018 - Adherence to sleep apnea treatment affects risk of hospital readmission
February 23, 2018 - Zika virus could be alternative for treatment of aggressive brain cancer
February 23, 2018 - Carbon monoxide enhances efficacy of antibiotic against stomach infection
February 23, 2018 - Study sheds light on biological mechanisms that drive rare pediatric neurogenetic disorders
February 23, 2018 - MSD and Ferring Pharmaceuticals Complete Largest Ever Clinical Trial in Postpartum Haemorrhage
February 23, 2018 - Portable ultrasound can help better detect fluid in the lungs of patients with end-stage kidney disease
February 23, 2018 - Postnova AF2000 system offers reliable characterization of trace metal colloid distribution in the environment
February 23, 2018 - Pioneering study may pave way for effective painkillers to treat neuropathic pain
February 23, 2018 - Research opens up new avenue to minimize risks of transplants
February 22, 2018 - Cabozantinib Active in Advanced Thyroid Cancer
February 22, 2018 - Polluted air may pollute our morality
February 22, 2018 - New data from VOYAGE 2 trial shows promising results for Janssen’s guselkumab treatment
February 22, 2018 - Bank loans signed in the hospital leave patients vulnerable
February 22, 2018 - Researchers identify new nanostructure inside sperm tails
February 22, 2018 - Catheter-based procedure increases treatment options for mitral valve disease
February 22, 2018 - Sage Therapeutics Receives FDA Breakthrough Therapy Designation for SAGE-217 for the Treatment of Major Depressive Disorder
FDA Approves Kaléo’s Auvi-Q (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

FDA Approves Kaléo’s Auvi-Q (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

image_pdfDownload PDFimage_print

Richmond, VA (November 20, 2017) kaléo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Auvi-Q (epinephrine injection, USP) 0.1 mg, the first and only epinephrine auto-injector (EAI) specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds (7.5 to 15 kilograms) who are at risk for or have a history of serious allergic reactions.

The sNDA for the Auvi-Q 0.1 mg Auto-injector was granted Priority Review by the FDA, an expedited regulatory pathway reserved for products that may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies.

Auvi-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. The new 0.1 mg-dose epinephrine auto-injector has a shorter needle length and lower dose of epinephrine than current FDA approved 0.15 mg and 0.3 mg epinephrine auto-injectors.

Children are increasingly being treated for anaphylaxis. There was a 129.8 percent increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014.[i] According to a study published in Allergy, Asthma & Clinical Immunology, 43 percent of children weighing 16.5 pounds (7.5 kilograms) to 33 pounds (15 kilograms) treated with a 0.15 mg EAI having a standard 12.7 mm needle length are at risk of having the needle strike the bone, therefore potentially impacting the administration of epinephrine during a life-threatening emergency.[ii] The needle length in Auvi-Q 0.1 mg was specifically designed for use with infants and small children to help mitigate this safety concern.

“Today’s decision by the FDA to approve the Auvi-Q 0.1 mg Auto-injector is exciting for all of us in the life-threatening allergy community who have been working for many years to fulfill this unmet medical need,” said Spencer Williamson, President and CEO of kaléo. “As a company that focuses on patients first, and providing potentially life-saving treatments, we are particularly glad we will be able to help caregivers by providing an EAI that was specifically designed with an appropriate dose and needle length for infants and children (16.5 to 33 pounds) in order to maximize the potential for a safe administration of epinephrine.”

“The approval of Auvi-Q 0.1 mg will help achieve our goal of working to fulfill unmet medical needs,” said Eric S. Edwards, MD, PhD, Vice President of Innovation and Research & Development at kaléo. “We developed the Auvi-Q 0.1 mg EAI to deliver a dose of epinephrine appropriate to infants and small children weighing 16.5 – 33 pounds, with a shorter needle length to help mitigate the risk of striking bone which could potentially cause injury or interfere with the delivery of epinephrine.”

Only Auvi-Q 0.1 mg has a dose and needle length designed specifically for treating anaphylaxis in infants and small children weighing 16.5 – 33 pounds. Auvi-Q 0.1 mg includes the innovative AUVI-Q electronic voice instruction system as well as visual cues to help guide users step-by-step through the administration.

“The approval of an epinephrine auto-injector specifically designed for infants and small children is timely, especially given the recent changes to guidelines recommending that certain high-risk infants, as young as four to six months old, be introduced to peanut-containing foods,” said Eleanor Garrow-Holding[1], President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). “We are pleased that the pediatric allergy healthcare community and parents of infants and small children with life-threatening allergies will have the ability to obtain an FDA-approved epinephrine auto-injector in the event of an allergic emergency. We look forward to the availability of Auvi-Q 0.1 mg.”

“Until now, healthcare practitioners and caregivers to infants and small children have not had an epinephrine auto-injector with an appropriate dose of epinephrine available to them, potentially causing some delay in the administration of epinephrine in a life-threatening allergic emergency,” said Dr. Vivian Hernandez-Trujillo[1], a pediatric allergist, and fellow of the American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; and American Academy of Pediatrics specializing in the management of life-threatening allergies and anaphylaxis. “Having an epinephrine auto-injector with a needle length and dose specifically designed for infants and small children should help alleviate concerns around hitting the bone or injecting too much epinephrine.”

Identical twin brothers, Evan and Eric Edwards, the inventors of Auvi-Q, know what it is like to live with life-threatening allergies, both as patients and parents of food-allergic children. Their goal was to develop an epinephrine auto-injector that contained innovative features, such as a voice instruction system that helps guide patients and caregivers step-by-step through the injection process. Evan and Eric Edwards believe and trust in Auvi-Q, not only for themselves, but also for their children and other families who may have to depend on it to administer epinephrine during an allergic emergency.

The Auvi-Q 0.1 mg Auto-injector is projected to be available for patients in the first half of 2018.

About Anaphylaxis

Anaphylaxis (pronounced ana-fuh-lak-sis) is a serious allergic reaction that happens quickly and may cause death. Anaphylaxis can occur as a result of exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens.

About Auvi-Q (0.3 mg, 0.15 mg and 0.1 mg)

Auvi-Q (epinephrine injection, USP) Auto-injector is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. Auvi-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.

Auvi-Q is the only compact epinephrine auto-injector with a voice instruction system that helps guide patients and caregivers step-by-step through the injection process, and a needle that automatically retracts following administration. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. Auvi-Q was designed through careful analysis of the situations where epinephrine auto-injectors are used and with significant input from the allergy community that relies on it incorporating Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error. For more information about Auvi-Q (0.3 mg, 0.15 mg and 0.1 mg) visit www.auvi-q.com.

About kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions. Our mission is to provide innovative solutions that empower patients to confidently take control of their medical conditions. We believe patients and caregivers are the experts on how their medical condition impacts their lives and are an integral part of our product development process. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit www.kaleopharma.com.

[1] Dr. Vivian Hernandez Trujillo and Eleanor Garrow-Holding are paid consultants of kaleo, Inc. and other private companies.
[i] Motosue M., et al. J Allergy Clin Immunol Pract. 2017;5:171-175.
[ii] Kim H., et al. Ann Allergy Asthma Immunol. 2017 Jun;118(6):719-725.

Source: kaléo

Posted: November 2017

Related Articles:

Auvi-Q (epinephrine) FDA Approval History

Tagged with:

About author

Related Articles