GLG News by Dr. Howard Weintraub MD, Clinical Director
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Another piece of good news for a very good drug
November 8, 2007
Ranexa(R) Significantly Reduces Incidence Of CV Death, MI Or Recurrent Ischemia In MERLIN TIMI-36 Patients With Elevated BNP | www.medicalnewstoday.com
By restoring function in the late Na channel and hence improving diastolic function (amongst other things), Ranexa has worked terrifically in my patients with any evidence for diastolic dysfunction. This typically manifests with shortness of breath and can be associated with an elevated level of BNP. This has not been as successful in patients without myocardial ischemia, but in those with ischemia the shortness of breath and associated chest discomfort has been helped in many. Including the most recent patient with a severe ischemic cardiomyopathy who has responded very very well with a significant increase in his functional capacity. Hopefully this news along with the safety from MERLIN and the A1C data and reduction in arrhythmias in that study will awaken docs to the benefits of Ranexa.
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November 8, 2007
Ranexa(R) Significantly Reduces Incidence Of CV Death, MI Or Recurrent Ischemia In MERLIN TIMI-36 Patients With Elevated BNP | www.medicalnewstoday.com
The good news gets better as there is now data from MERLIN that corroborates the news from CARISA showing a reduction in HbGA1C that was significant.
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June 15, 2007
FDA Advisory Committee Did Not Recommend Approval Of Rimonabant (ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors | www.medicalnewstoday.com
It is clear that the panel felt that there was inadequate data on the psychiatric implications of rimonabant. It is a strong statement coming in the wake of the rosiglitazone mess (with strong recollections of cerivastatin and Vioxx) demonstrating that the FDA will be very finicky about approvals in the near and mid-term future. This does not bode well for Sanofi, who will not have to regroup and pray for success with son of Amiodarone.
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June 15, 2007
FDA Advisory Committee Did Not Recommend Approval Of Rimonabant (ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors | www.medicalnewstoday.com
It is clear that the advisory panel is more concerned with safety in a limited population that the broader impact of obesity and its metabolic problems and acceleration of diabetes and atherosclerosis. This demonstrates the likelihood that the FDA will likely be posturing to reflect the rosiglitazone mess (with Baychol and Vioxx undertones). This is going to create a real challenge for Sanofi and make them pray for succes with the "son of amiodarone".
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