Document Detail


Omapatrilat. Bristol-Myers Squibb.
MedLine Citation:
PMID:  11890357     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Bristol-Myers Squibb (BMS) is developing the vasopeptidase inihibitor, omapatrilat, a dual inhibitor of angiotensin converting enzyme (ACE) and neutral endopeptidase (NEP), for the potential treatment of cardiovascular diseases such as hypertension and heart failure [306287]. An NDA for the use of omapatrilat in hypertension was filed with the FDA and the regulatory authorities in the EU in December 1999 [351207], [353287]. In April 2000, BMS voluntarily withdrew the NDA in response to questions raised by the FDA regarding the comparative incidence and severity of an infrequent side effect (angioedema) reported within the NDA database. Prospective controlled clinical studies in patients with hypertension and heart failure were to continue. In May 2001, BMS reported that its blinded omapatrilat hypertension study was continuing and, pending supportive results from a data analysis anticipated in late summer/early autumn 2001, the company expected to refile an NDA with the FDA [409203]. In July 2000, BMS reported that it planned to conduct a multinational, 25,000 patient study (OCTAVE - Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril) to compare the efficacy and safety of omapatrilat against enalapril in the treatment of hypertension [374909]. The OCTAVE trial was expected to generate data by mid-2001, which could allow for a launch by early 2002 [380280]. Phase III trials for hypertension had commenced by January 1998 [273646]. In January 2001, Merrill Lynch expected BMS to refile its NDA with the FDA in the second half of 2001 [395423]. In February 2001, Credit Suisse First Boston made a similar prediction, adding that it believed BMS would launch the drug in late 2002 or early 2003. The analysts also predicted peak sales for the drug of $585 million in 2005 [399484]. In May 2001, Merrill Lynch estimated sales of $1.8 billion in 2005 [411811].
Authors:
R Tabrizchi
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Current opinion in investigational drugs (London, England : 2000)     Volume:  2     ISSN:  1472-4472     ISO Abbreviation:  Curr Opin Investig Drugs     Publication Date:  2001 Oct 
Date Detail:
Created Date:  2002-03-13     Completed Date:  2002-10-30     Revised Date:  2014-01-09    
Medline Journal Info:
Nlm Unique ID:  100965718     Medline TA:  Curr Opin Investig Drugs     Country:  England    
Other Details:
Languages:  eng     Pagination:  1414-22     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Angiotensin-Converting Enzyme Inhibitors / adverse effects,  metabolism,  pharmacology,  therapeutic use*,  toxicity
Animals
Clinical Trials, Phase I as Topic
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Heart Failure / drug therapy*
Humans
Hypertension / drug therapy*
Pyridines / adverse effects,  metabolism,  pharmacology,  therapeutic use*,  toxicity
Structure-Activity Relationship
Thiazepines / adverse effects,  metabolism,  pharmacology,  therapeutic use*,  toxicity
Chemical
Reg. No./Substance:
0/Angiotensin-Converting Enzyme Inhibitors; 0/Pyridines; 0/Thiazepines; 36NLI90E7T/omapatrilat

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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