FDA issues complete response letter for Zuplenz
WOODCLIFF LAKE, N.J. The Food and Drug Administration has declined to approve a drug made by Strativa Pharmaceuticals for preventing sickness resulting from some cancer treatments, Strativa said Friday.
The FDA issued a complete response letter for Strativa’s approval application for Zuplenz (ondansetron), an oral-soluble film for preventing nausea and vomiting associated with certain types of chemotherapy, radiotherapy and surgery. The FDA cited an agency-wide restriction on travel in India that prevented it from inspecting the clinical and analytical sites for a bioequivalence study.
Strativa said it would work with the FDA to complete inspections of the sites, while the FDA said it would try to perform an inspection as soon as it could.
Artificial pancreas may benefit young Type 1 diabetes patients
LONDON Sleeping overnight with an artificial pancreas system benefits children and teenagers with Type 1 diabetes, according to a study published in the Feb. 5 issue of The Lancet.
The study, funded by the Juvenile Diabetes Research Foundation and conducted by researchers at the University of Cambridge in England, had participants aged 5 to 18 spend the night in a hospital using a combination of commercially available blood glucose sensors and insulin pumps controlled by a computer program that determined insulin dosage based on blood glucose levels.
The study found that the patients had targeted blood glucose levels for twice as long when they used the artificial pancreas system than when they used conventional therapy.
“These studies show that automated systems not only can help people manage diabetes by maintaining good control, they will also improve quality of life for the people with Type 1 diabetes and their families by lowering the risk of hypoglycemia,” University of Cambridge Institute of Metabolic Science researcher and lead study author Roman Hovorka said. “These results suggest that closed-loop devices may be able to significantly lower the patient’s risk of developing complications later in life by reducing or even overcoming the burden of hypoglycemia.”
FDA issues warning over safety of Tysabri use
ROCKVILLE, Md. Patients using a drug for treating multiple sclerosis may be at increased risk of developing a deadly brain infection, the Food and Drug Administration said Friday in a warning to healthcare professionals and patients.
The FDA said that 31 patients using the drug Tysabri (natalizumab), marketed by Elan Corp. and Biogen Idec, had developed progressive multifocal leukoencephalopathy, or PML, as of Jan. 21. The drug’s safety labeling has been updated to reflect the risk. Still, the agency said the benefits of the drug outweigh the potential risks.
PML is caused by the JC virus, a virus that occurs naturally in most adults but is kept in check by the body’s immune system. When the immune system becomes compromised due to diseases such as AIDS or the use of immune-suppressing drugs, the risk that the virus will multiply and cause irreversible and fatal damage to the brain increases.