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.
Camber appoints new president
PISCATAWAY, N.J. — The U.S. subsidiary of India-based generic drug maker Hetero Drugs has appointed Konstantin Ostaficiuk as its president, Camber said.
Ostaficiuk, who often goes by the nickname of Kon, succeeds Briggs Arrington, who has gone on to work for Hetero’s senior management team to find new opportunities for the company’s U.S. manufacturing operations. Ostaficiuk has worked in the generic drug industry for 25 years, having joined Camber in 2009 as VP sales and marketing.
“Camber and Hetero have a very robust pipeline and will continue to introduce and launch significant new products to our current portfolio in the remainder of 2011, 2012 and on into the future,” Ostaficiuk said. “We are committed to providing the highest level of quality and service available as we grow our business and our product line.”