Ok, a day late with the Roundup. Apologies. I was really busy.
The countdown is ticking respecting the work of the Super Committee that many fear may be turning out not to be so Super at all and will certainly be called Super “something” if the work they have before them goes undone. The leaves are shimmering a vast array of beautiful autumn colors. Mulling spices and apple juice are in stores. And so it is otherwise a wonderful time of year.
And here are a few things that happened this week:
- FDA Approves Xarelto – The big approval news of the week was the FDA’s announcement that it was giving the thumb’s up to Janssen’s Xarelto for the prevention of stroke in people with a common type of abnormal heart rhythm (non-valvular atrial fibrillation). However the approval came not only with a Medication Guide, but a Boxed Warning as well. Xarelto had been approved July 1, 2011 for certain types of blood clots as well.
- FDA Approves First Heart Valve Placed Without Open Heart Surgery – This week the agency announced the approval of a new aortic heart valve that, yes, can be placed without open heart surgery to treat senile aortic valve stenosis – a condition that kills half of patients after two years once symptoms appear. The Sapien THV is made of cow tissue and polyester supported with a stainless steel mesh frame and is manufactured by Edwards Lifescience. Details on how the device is inserted can be found in the FDA’s press release and is worth a read.
- FDA Approves 35 New Drugs in Past Year – And speaking of approvals, the FDA announced that this past year saw more drug approvals than at any time in the past decade with the exception of 2009. The 35 drugs approved in the past year included some of special note, including game changers in the treatment of Hepatitis C, the first non-Hodgkins lymphoma treatment in 30 years and the first lupus drug in 50 years. Ten of these approvals were for orphan drugs and 16 occurred under priority review conditions and three had accelerated approvals. It is good to get perspective and even better when the view is a good one. For more details, see the FDA’s release on the milestone.
That’s it for me this week. Again sorry to be tardy.