《阿托伐他汀钙汤姆森报告》由会员分享，可在线阅读，更多相关《阿托伐他汀钙汤姆森报告（333页珍藏版）》请在金锄头文库上搜索。
1、.2010 THOMSON REUTERS. For more information go to http:/ .DRUG REPORT : atorvastatin . SUMMARY .Drug NameatorvastatinCompanyParke-Davis Prophylaxis (Adult), Disorder Of Cardiovascular System, In Patients With Multiple Risk Factors For Coronary Heart Disease; Prophylaxis (Adult), Familial Hypercholes
2、terolemia - Homozygous, Adjunct (Adult), Disorder Of Cardiovascular System, Secondary; Prophylaxis (Adult)Therapy AreasAlzheimers disease; Hypercholesterolemia; Hyperlipidemia; Familial hypercholesterolemia; Cerebrovascular ischemiaActionsHMG CoA reductase inhibitor; Antiarteriosclerotic; Nootropic
3、agent; CNS modulator; Antihypercholesterolemic agent; Antihyperlipidemic agentTechnologiesOral formulation; Tablet formulation; Small molecule therapeuticTargetHMG CoA reductaseUpdate date27-DEC-2010Reason for updateMinor Editorial Amendment. OVERVIEW . Atorvastatin (Lipitor; Sortis; Lipramar; Preve
4、ncor) is an oral HMG-CoA reductase inhibitor and synthetic lipid- lowering agent, developed and launched by Pfizer. The product is indicated for the treatment of primary hyperlipidemia, mixed dyslipidemia and dysbetalipoproteinemia, to prevent cardiovascular disease in patients with multiple risk fa
5、ctors, and to reduce the risk of MI, stroke, revascularization procedures and angina in patients without cardiovascular disease but with multiple risk factors, including in patients with type 2 diabetes 509594, 509597. . Atorvastatin was approved in the UK and Germany in December 1996 for hyperchole
6、sterolemia 227414. US launch took place in February 1997 238967, 1029355. Japanese launch took place in May 2000 507267. . In April 2004, a supplemental filing was made in the EU to include results of the REVERSAL trial on the label 550263. The FDA also approved a label expansion for the prevention
7、of cardiovascular disease in August.2010 THOMSON REUTERS. For more information go to http:/ .2004, allowing the claim of reducing heart attack risk in patients with normal to mildly elevated cholesterol levels who have other cardiovascular risk factors 557066, 565489. In September 2005, the FDA furt
8、her extended the label to include the reduction of the risk of stroke and heart attack in type 2 diabetics without evidence of heart disease but with other risk factors 681887. The EU applied the same extension in June 2006 678324. The US label was again extended in March 2007 to include patients at
9、 high risk for cardiovascular events because of established heart disease 771735. In July 2010, an extension was granted in the EU, for use in pediatric patients aged 10 years and older with hypercholesterolemia, which included a new chewable formulation of a pediatric-appropriate 5 mg dose 1114011.
10、 . By March 2010, the drug was also being developed for familial hypercholesterolemia in pediatric patients 1079318. . In 2002, Pfizer reported that it planned to investigate atorvastatin in other therapeutic areas, including peripheral vascular disease, osteoporosis and Alzheimers disease (AD). The
11、 company also intended to further evaluate the use of atorvastatin in treating diabetics, the elderly and post-menopausal women. At that time, the company aimed to conduct over 180 trials involving more than 100,000 patients 443922. By July 2005, a pilot study showed that atorvastatin use in AD pati
12、ents slowed cognitive decline and depressive symptoms over one year 550263. In April 2008, negative AD data were reported and the company commented that it was not planning any additional AD studies at that time 897847. . Pfizer also markets Caduet (atorvastatin plus amlodipine). . PATENT AND GENERI
13、CS INFORMATION The US The US basic patent for atorvastatin expired in March 2010 (including the pediatric exclusivity period). A patent covering the enantiomeric form of the drug expires in June 2011 (including the pediatric exclusivity period) 1085323. One of the five listed patents was rejected by
14、 the USPTO in June 2005; Pfizer was considering its response 610767, 608958. In November 2005, the USPTO confirmed the validity of the US patent covering the crystalline form of atorvastatin calcium. . By August 2003, Ranbaxy Laboratories was investigating generic Lipitor with a view to possible lau
15、nch in 2006 519019, 519027, 519020. In December 2004, a US trial concluded between Pfizer and Ranbaxy; to launch generic Lipitor before 2010, Ranbaxy had to prove non-infringement of US-04681893 and ensure that US-05273995 was declared invalid 581959. In December 2005, a US Federal Court ruled in fa
16、vor of Pfizer, ensuring exclusivity until June 2011. The Court held that Ranbaxys atorvastatin infringes Pfizers US-04681893, and upheld the validity of US-05273995. Ranbaxy stated that it would appeal the decision 644180. On appeal, the lower court decision on US-05273995 was overturned, although the validity of US-04681893 was maintained, which could have allowed Ranbaxy to launch it
