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Biotech / Medical : Cardiome -- CRME -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (265)8/11/2008 10:18:37 AM
From: former_pgs  Read Replies (1) | Respond to of 285
 
>Prior to considering approval, FDA requires additional information associated with the risk of previously identified events experienced by a subset of patients during the clinical trials in order to assure an acceptable risk benefit profile compared to electrical cardioversion. FDA has also requested a safety update from ongoing or completed studies of vernakalant, regardless of indication, dosage form, or dose level.<

The safety updates are routine, but the fact that the request in the first sentence is expressly separate from the request in the second sentence makes me think they will need some new data.

On a related matter, I've heard rumblings that the FDA is considering pulling water off the market...



To: tuck who wrote (265)8/11/2008 11:08:36 AM
From: idos  Respond to of 285
 
I believe the "subset" refers to the severe congestive heart failure (CHF) patients group, in which some also had ventricular dysfunction.



To: tuck who wrote (265)10/9/2008 12:44:36 PM
From: tuck  Read Replies (1) | Respond to of 285
 
>>Cardiome Provides Regulatory Update
Thursday October 9, 12:20 pm ET

VANCOUVER, Oct. 9 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that it has been informed by its co-development partner, Astellas Pharma US, Inc., that an End of Review meeting with the U.S. Food & Drug Administration (FDA) has been scheduled for November 14th, 2008 regarding the New Drug Application (NDA) for KYNAPID(TM) (vernakalant hydrochloride) Injection for rapid conversion of atrial fibrillation to sinus rhythm. At the conclusion of FDA's review of an application and the issuance of an action letter, FDA provides applicants with an opportunity to meet with agency reviewing officials to discuss what further steps need to be taken by the applicant before the application can be approved.

Cardiome has also been informed by Astellas that, in an effort to align the North American regulatory strategy, Astellas has elected to withdraw the New Drug Submission (NDS) for KYNAPID with the Therapeutic Products Directorate (TPD) of Health Canada, originally submitted in May 2007. Cardiome and Astellas intend to revisit the Canadian regulatory strategy following resolution of the FDA process.

"Since receiving the FDA Approvable Letter in August, Cardiome and Astellas have been working diligently to collate information and analyses relevant to the issues raised in the action letter, and this meeting is intended to provide us with clear guidance so that we can focus our efforts on providing a robust response and attain U.S. approval for KYNAPID," said Bob Rieder, Chief Executive Officer of Cardiome. "We look forward to working with the FDA with the goal of having KYNAPID available to appropriate patients as soon as possible."<<

snip

Cheers, Tuck