The heat of summer seems to have gotten the hint and abated somewhat. The news is swirling around Washington like bees around a hive at the end of summer. We all enter our back to school mentality. I am no exception, and have posted every day, sometimes twice this week. In the meantime, here is a little of what happened this week:
- Merck’s New HIV Drug Gets Advisory Panel Backing – The Antiviral Drugs Advisory committee unanimously voted in favor of approving ISENTRESS™ (raltegravir) , the first of a new class of antiretroviral agents called integrase inhibitors. The drug is used "in combination with other antiretroviral therapy for the treatment of HIV infection in treatment-experienced patients with ongoing viral replication despite existing therapy." The approval date should be sometime in mid-October, given the fact that it is now on a 6-month track for consideration.
- Britain to Consider Hybrid Embryos – In a development sure to be controversial, the British government is considering the ok for embryos to be developed that are part human, part animal. Being created for medical purposes, the practice is sure to engage many in an ethical debate. You can count on members of Congress, in order to pander to a conservative base, will introduce legislation specifically banning this practice in the United States.
- Thumbs Down on Encysive Dispute Resolution for Thelin – As noted in a posting here at Eye on FDA at the time Encysive was making known its efforts, a dispute resolution process is not a promising one in general. Nor, it seems, was it productive for Encysive with respect to the FDA determination on Thelin. After three approvable letters and a dispute resolution, the company received notice from the FDA that said, according to the company’s press release, the agency’s "reviewer agreed with the decision of the Division of Cardiovascular and Renal Products that, while the data provided in the NDA are suggestive of the effectiveness of Thelin, it did not provide the substantial evidence of effectiveness needed for approval. The reviewer encouraged the Company to conduct an additional study to demonstrate the drug’s effectiveness in exercise capacity as measured by change in six-minute walk distance. "
Have a good weekend everyone.