GSK no longer will seek approval for Avodart
LONDON — GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men’s risk of developing prostate cancer.
The drug maker announced it no longer would pursue global approval for Avodart (dutasteride) and would work with regulatory agencies to remove the indication from the product’s license.
In late 2009, GSK began filing applications with regulatory agencies worldwide for the use of dutasteride to reduce the risk of prostate cancer. The drug maker received a complete response letter from the Food and Drug Administration’s Oncologic Drugs advisory committee this past January, which ruled against Avodart’s favorable risk/benefit profile for reduction in the risk of prostate cancer in men at risk for the disease.
Novo Nordisk says Levemir is effective in treating young Type 1 diabetes patients
COPENHAGEN — Novo Nordisk said new data showed that its basal insulin analog is just as effective as human basal insulin in Type 1 diabetes patients ages 2 to 5 years.
According to clinical data published in Pediatric Diabetes, among a sub-group analysis of a full cohort of children ages 2 to 16 years — the full cohort is expected to be published in a relevant journal later this year — children ages 2 to 5 years treated with Levemir and a fast-acting insulin analog, NovoRapid (insulin aspart), experienced a lower rate of hypoglycemia, compared with those taking human basal insulin and NovoRapid.
Although no statistical analysis has been conducted due to the low number of patients in this age group, the hypoglycemic risk differences follow the same patterns that were revealed in the overall cohort in which differences proved to be statistically significant, the drug maker said.
No basal insulin analog currently is recommended for children in this age group, Novo Nordisk noted. It also added that it now is working to update the Levemir label.
”If our application for a label update is successful, Levemir will be the first basal insulin analog with an indication extended to this very young patient population. It will also be the second Novo Nordisk insulin analog after NovoRapid that will cover this group," said Kirstine Brown Frandsen, corporate VP global medical affairs at Novo Nordisk. "We believe this confirms our long-term commitment to developing treatments for all patients with improved safety profile.”
Qualitest’s toresmide tablets approved by FDA
HUNTSVILLE, Ala. — The Food and Drug Administration has approved a generic drug for cardiovascular disease made by Qualitest Pharmaceuticals.
Qualitest announced Thursday the approval of toresmide tablets in the 5-mg, 10-mg, 20-mg and 100-mg strengths.
The drug is used to treat edema associated with congestive heart failure, kidney disease or hepatic disease, and also for hypertension.