AstraZeneca submits sNDA for NEXIUM (esomeprazole magnesium)
The U.S. Food and Drug Administration has approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple
Full Post: FDA approves Mozobil (plerixafor) for multiple myeloma or non-Hodgkin’s lymphomas
AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NEXIUM(R) (esomeprazole magnesium) to seek approval for the short-term (up to 6 weeks) treatment of gastroesophageal reflux disease (GERD) in pediatric patients ages 0 to 1 year old.
GERD is a condition in which the contents of the stomach back up into the esophagus. Though it is often associated with adults, GERD also affects approximately 7 million children in the United States, causing symptoms such as pain, irritability, constant or sudden crying and frequent vomiting.(1) Although physiologic non-painful regurgitation is normal in the first year of life, a proportion of these infants may have persistent symptoms diagnosed as GERD that could require treatment with an acid-suppressive drug to help resolve the problem.(2)
NEXIUM is in a class of drugs known as proton pump inhibitors (PPIs) and was approved by the FDA for the short-term treatment of GERD in adolescents 12 to 17 years old in April 2006, and in children 1 to 11 years old in February 2008.
“An important medical need exists in infants younger than 1 year old, which is an often overlooked GERD population,” said Marta Illueca, MD, FAAP, NEXIUM Brand Medical Director, AstraZeneca Pharmaceuticals, LP, U.S. “While some reflux and regurgitation are normal in infants and may not require medical treatment, persistent GERD symptoms can be very uncomfortable and cause damage to the esophagus, just as they can in older patients. Close medical supervision is key in the appropriate diagnosis and choice of treatment for these infants.”
To ensure age-appropriate dosing and administration for the 0 to 1 year old patient population, AstraZeneca also filed for approval of 2.5 mg and 5 mg strengths of NEXIUM(R) (esomeprazole magnesium) for Delayed-Release Oral Suspension. This granular formulation, which is mixed with water to form a suspension that is administered orally or via feeding tubes, is currently available by prescription in 10 mg, 20 mg and 40 mg strengths. The formulation contains esomeprazole magnesium, the same active ingredient used in NEXIUM Delayed-Release Capsules.
The sNDA submission for NEXIUM in infants ages 0 to 1 year old is based on 3 studies performed in 167 infants ages 0 to 11 months. The first two studies provided data about the clinical pharmacology of NEXIUM in these young infants. The third study looked at the safety and effectiveness of NEXIUM in infants with various clinical manifestations of GERD. In this study, NEXIUM was well tolerated in these age groups and no new safety signals were detected.
For first-line treatment of pediatric GERD, families are encouraged to try lifestyle modifications, such as smaller, more frequent meals or dietary changes. If these methods fail, physicians at present have very few approved pharmacological options. At the time of this submission, no PPI is FDA approved for the treatment of GERD in infants younger than 1 year old.
Approximately 60 million American adults experience gastroesophageal reflux disease (GERD) symptoms more than twice a week.(3) GERD is characterized by frequent and persistent heartburn, which occurs when the lower esophageal sphincter (the valve separating the esophagus and stomach) does not close properly, allowing acid to back up into the esophagus. GERD is chronic and, if left untreated, may potentially lead to more serious medical conditions such as erosive esophagitis.
The exact prevalence and frequency of GERD in children is unknown, as there are very few medical studies reporting the incidence of GERD symptoms in children. One study, a cross-sectional survey, looked at the prevalence of regurgitation in healthy infants 13 months old and younger. The study included a total of 948 parents of infants 13 months old and younger. Peak regurgitation was reported 23% of the time at 6 months. A proportion of these infants may have persistent symptoms diagnosed as GERD.(2) Close medical supervision is key in the proper diagnosis and choice of treatment for these infants.
In adults, NEXIUM is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions.
NEXIUM was approved in April 2006 for the short-term treatment (up to 8 weeks) of GERD in adolescent patients 12 to 17 years old. NEXIUM was also approved for the short-term treatment (up to 8 weeks) of GERD in children 1 to 11 years old in February 2008. The approvals are supported by extrapolation of results from adequate and well-controlled studies that supported the approval of NEXIUM for adults, and safety and pharmacokinetic studies. The safety and effectiveness of NEXIUM for other pediatric uses other than GERD have not been established.
In adults, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, and abdominal pain. In patients 1 to 17 years of age, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, abdominal pain, nausea, and sleepiness. Symptomatic response to therapy does not preclude the presence of gastric malignancy. NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information.
For more information visit: www.NEXIUM-US.com.
Two non-surgical, non-pharmacological treatments for gastroesophageal reflux disease (GERD) both appear effective in reducing medication use and improving voice and swallowing symptoms, according to a report in the January issue of Archives of Surgery. One type of therapy also appears effective for reducing heartburn and cough, whereas the other may be associated with a reduction
Full Post: Non-surgical, non-pharmacological treatments for gastroesophageal reflux disease compared
Chronic gastrointestinal symptoms are highly prevalent in different geographic populations and cause various gastrointestinal symptoms that greatly inconvenience the lives of those affected. Examples include GERD, uninvestigated dyspepsia, irritable bowel syndrome, and chronic constipation. These problems have an impact on the individual’s quality of life. There is a lack of community-based research evaluating the impact
Full Post: Chronic gastrointestinal symptoms in Korean population
Prilosec is one of the best anti acid drugs that has been approved by the FDA as the best treatment for gastroesophageal reflux disease and gastric ulcers. According to the health professionals, a lot of acid in the stomach may lead to acid reflux. Prilosec performs its duties by blocking the enzymes that stimulate the
Full Post: Prilosec is one of the best anti acid drug
Researchers at the University of Pennsylvania School of Medicine have discovered stem cells in the esophagus of mice that were able to grow into tissue-like structures and when placed into immune-deficient mice were able to form parts of an esophagus lining. The investigators report their findings online this month in the Journal of Clinical Investigation.
Full Post: Newly discovered esophagus stem cells grow into transplantable tissue
After a doctor at Adelaide’s Women’s and Children’s Hospital tested positive for tuberculosis (TB), authorities say as many as 300 babies have been identified who may have come into contact with the doctor and could be at risk. About 75 of the children are too young to be tested but have been given preventive
Full Post: As many as 300 children could be at risk of TB from hospital doctor