Tuesday, June 19, 2012

Failure because of toxicity? No way!


There are a couple of reports regarding intolerable toxicity shown in clinical trials of Carfilzomib (see here and here):

Side effects for the treatment, known chemically as carfilzomib, also included cardiac arrest and shortness of breath, the FDA staff said. More than 70 percent of patients had lung complications with the drug, according to the FDA report.

Well, you may say that the drug is a failure... FDA basically should have the same opinion:

The agency “is very concerned with the severe toxicities, including deaths that are associated with the use of this agent,” the FDA staff said in the report.

However, do you know what? The clever experts who know this industry and understand how the things work, yes, they expect that the drug will be definitively approved! No doubt about it if the potential profit is so huge:

“This is a drug that will get approved,” Michael King, an analyst with Rodman & Renshaw in New York, wrote in an e-mail today. “It’s just a matter of when.”

If approved, yearly sales for the drug may be $523 million in 2016, according to the average of five analysts’ estimates compiled by Bloomberg.

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