昨天，10-25-06，FDA批准替比夫定（Telbivudine）作为治疗慢性乙肝药物上市。商品名为：Tyzeka。就是Ldt。 Novartis drug for chronic hepatitis B gets FDA nod
Reuters
October 25, 2006
Tyzeka offers prescribers another option for treating these patients
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on
Wednesday it has approved Novartis AG's telbivudine once-a-day drug for
treating adults with chronic hepatitis B, a viral infection that attacks the
liver.
During clinical studies of the drug, also known as Tyzeka, it was generally
well tolerated and most adverse events were mild to moderate, the FDA said
in a statement.
Approximately 70,000 Americans are infected with chronic hepatitis B
annually and 5,000 of them die from complications of the disease, according
to the FDA. It is sometimes spread through sexual contact or blood
contamination.
"Tyzeka offers prescribers another option for treating these patients," Dr.
Steven Galson, director of the FDA's Center for Drug Evaluation and
Research, said in a statement.
Common side-effects of Tyzeka included elevated levels of an enzyme that can
lead to muscle weakness, upper respiratory tract infection, fatigue,
headache, abdominal pain and cough, the FDA said.
Some patients who used the drug for several weeks to months experienced
transient muscle pain to muscle weakness, but they saw improvements when
they stopped using Tyzeka, according to the government agency.
Novartis in 2003 partnered with Idenix Pharmaceuticals and obtained a
license for the company's telbivudine product candidates. Novartis also
acquired a majority stake in Idenix.
The FDA also said that using Tyzeka has not been shown to reduce the risk of
infecting others with hepatitis B through sexual contact or blood
contamination.
http://www.topix.net/content/reuters/1842610348164714349620570117752580500610 [此贴子已经被作者于2006-10-27 8:34:14编辑过]
| 
发表于 2006-10-27 18:47
