Novartis says new drug to improve lung functions

The Swiss pharmaceutical company Novartis announced Thursday that it has a new a drug which will offer better help to sufferers of chronic obstructive pulmonary diseases, such as chronic bronchitis and emphysema.

The QAB149 drug, after phase III trials, showed it could deliver improved lung function within five minutes of the first dose, lasting for 24 hours. This would mean suffers would only need one dose a day.

Chronic obstructive pulmonary diseases can be life-threatening respiratory diseases that affect some 210 million people worldwide, mostly as a result of smoking cigarettes or inhalation of other fumes.

The World Health Organization estimates the diseases are becoming one of the leading causes of deaths worldwide.

QAB149 is currently undergoing regulatory review in the European Union and the United States.

Source : www.monstersandcritics.com

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New drug combo to help infants breathe easier

An Ottawa doctor has found a combination of drugs that could reduce the number of babies admitted to hospital for a common lung infection by 35 per cent.

In Canada, about 35 in 1,000 babies are hospitalized with bronchiolitis — an inflammation of the tiny airways in the lungs — each year, usually for two to four days. The costs to the medical system are considerable: $700 million in the United States, and at least $23 million at last report in Canada.

Bronchiolitis is the biggest culprit among infections that land young children in the hospital, according to Amy Plint, pediatric emergency physician at the Children’s Hospital of Eastern Ontario, and associate professor in pediatrics and emergency medicine at the University of Ottawa. Plint is the lead author of a paper, to be published today in the New England Journal of Medicine, explaining the new treatment .

Infants typically begin with a viral infection, cough and runny nose, then develop ragged, wheezing breath that can result in depleted blood oxygen. Because their noses are stuffy, they also can’t feed properly as they struggle to breathe and suck at the same time. The symptoms can linger for three weeks.

The adrenal hormone, epinephrine, and the steroid, dexamethasone, “together produced surprising results,” said Plint. Epinephrine relaxes the muscles and opens the airways while the steroid reduces inflammation. The two have been administered separately in pediatric emergency rooms, but to no great effect. Epinephrine can cause a baby’s heart rate to rise slightly, but so will struggling to breathe. The steroid can cause bleeding from the bowel or gut, irritability and complications with chicken pox. Clinicians watched the babies in the study for any of these side effects, and found nothing.

“To date, there have been no clear treatment options other than giving babies oxygen if their oxygen levels were low and fluids if they weren’t feeding,” said Terry Klassen, a pediatrics professor at the University of Alberta, and co-author of the paper.

The study looked at 800 babies in eight pediatric hospitals across the country. Parents brought their children, from six weeks to 12 months old, to the local emergency departments with bronchiolitis.

The children in the study were randomly assigned

to one of four groups: two groups got one or the other of the drugs; the third group got no drugs, and the fourth group got both. The babies that got both recovered much more quickly. A follow-up a week later found that 35-per-cent fewer required hospital admission.

“Thirty-five per cent is a substantial drop,” said Plint. “These findings are truly significant to the health-care system and to families of young children around the world.”

Plint said she anticipates the drugs would be administered at the emergency department, not by family doctors.

David Johnson, a professor of pediatrics at the University of Calgary, also worked on the paper: “One in three children has at least one wheezy episode before their third birthday. We anticipate insights from our study will lead to follow-up studies that may ultimately improve how we care for all these children.” Plint would like to do further studies to see if lower doses were equally as effective.

The Canadian Institutes of Health Research spent $1.96 million on the study, with additional funding from the Alberta Children’s Hospital Foundation.

Source : www.ottawacitizen.com

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Cystic Fibrosis - Orphan Drug Designation for Innovative Treatment Against Lung Infections

An innovative treatment for infections of the respiratory tract in cystic fibrosis patients has received orphan drug designation in the US.

Axentis Pharma of Zurich, Switzerland announced today that this sought-after designation has been granted to its product candidate Fluidosomes-tobramycin, a therapeutic that will soon be tested in Phase II clinical trials. The company has now been granted orphan drug designation for this candidate in both Europe and the US.

Axentis Pharma (Switzerland) announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted the orphan drug designation to its lead product candidate Fluidosomes-tobramycin. This drug is a liposomal formulation of tobramycin, an innovative treatment for infections of the respiratory tract in patients with cystic fibrosis that is delivered directly to the site of infection via standard nebulizers. Pre-clinical and Phase I clinical studies support improved safety and efficacy profiles for Fluidosomes-tobramycin as compared to currently marketed treatments for infections of the respiratory tract in patients with cystic fibrosis.

The orphan drug designation is granted with respect to treatment of pulmonary infections caused by Pseudomonas aeruginosa, a bacterium that is one of the most common causes of infections of the respiratory tract in patients with cystic fibrosis. Axentis Pharmas product candidate received the orphan drug designation for the US only two months after the application and less than one year after orphan designation in Europe was transferred to the company. Dr. Helmut Brunar, company CEO and President, comments: "The orphan drug designation for the US is very good news for affected patients as well as for Axentis Pharma's shareholders. Together with the Orphan Drug Designation that was already achieved last year in Europe, the US .

Source : www.bio-medicine.org

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