Please login to the form below

Not currently logged in
Email:
Password:

Daiichi-Sankyo gains FDA sNDA for Welchol

The US FDA has approved a supplemental new drug application for Daiichi-Sankyo's cholesterol drug Welchol

The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Daiichi-Sankyo's cholesterol drug Welchol.

The sNDA allows Welchol (colesevelam HCl) to be for the reduction of elevated low-density lipoprotein cholesterol (LDL-C), used as an adjunct to diet and exercise, in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH). The drug can be used alone or in addition to a statin once an adequate trial of diet therapy has been tried and failed.

"The FDA approval of Welchol for children with inherited high cholesterol provides another important treatment option for these children, whose elevated LDL cholesterol puts them at increased risk for cardiovascular disease," said Dr Evan A. Stein, director, Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio. "The pivotal trial of Welchol in this paediatric patient population demonstrated that Welchol, as monotherapy or when combined with a statin, significantly reduced LDL-C."

Welchol was approved in 2000, as an adjunct to diet and excerices, as a treatment to lower LDL-C cholesterol in adults with primary hyperlipidemia and to improve glycemic control in adults with type 2 diabetes mellitus. In 2008 it was approved to lower A1C in adults.

12th October 2009

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Nobull Communications

Switched on Creative Communications. With an encyclopedic working knowledge of pharmaceutical industry rules and regulations, we create dynamic, intuitive and...

Latest intelligence

How can pharma engage with key stakeholders on NHS service transformation?
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare consulting team, explain how pharma should make its case for change...
michael elliot
The race for an HIV ‘cure’
Supercharging therapies as pharma and patients work together...
Medopad: the up and coming unicorn transforming remote patient monitoring
Blue Latitude Health speaks to Medopad’s Martha Carruthers to learn how the start-up’s modular apps are helping patients with complex diseases....

Infographics