Today is supposed to mark the day that the FDA quits submitting approvable letters and starts issuing "complete response letters" – but it looks like one flew off the shelf just in the nick of time – at least per the headline on the press release from Cardiome.
Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US, Inc. (“Astellas”) today announced that they have received an action letter dated August 8, 2008 from the U.S. Food and Drug Administration (FDA) for KYNAPID™ (vernakalant hydrochloride) Injection for the treatment of atrial fibrillation (AF) – a potentially life-threatening condition that occurs when electrical signals in the heart malfunction. KYNAPID is under review for the rapid conversion of AF to sinus rhythm. This once again, in my mind, demonstrates how difficult cardiac pharmacological research is in today’s environment.
It is not clear from the language of the press release that refers to the letter what precise actions must be taken in order to gain approval. Rather, the agency is seeking safety/risk information about a particular subset and whether or not that data needs to be created or exists somewhere is not clear.
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.
Bob Rieder, Chief Executive Officer and Chairman of Cardiome is quoted as saying “While this action letter could result in the need for an additional clinical study, Cardiome is optimistic that the questions raised can be satisfactorily addressed from currently available data.” An additional clinical study would likely add months to the approval.
So far, as of this writing at approximately 11AM, Cardiome’s stock has lost almost 27%, or $3.14.