Break Out The Press Release: FDA OKs Amgen Drug
2 CommentsBy Ed Silverman // August 22nd, 2008 // 12:28 pm
The FDA has finally approved the biotech’s Nplate blood clotting drug, although the agency only approved its use for patients who fail to respond to other treatments. FDA approval was due on July 24, but the endorsement never materialized.
In mid-July, however, BusinessWire issued a press release saying the FDA had, indeed, approved Nplate, albeit with certain risk management requirements. The premature release embarassed Amgen, which forced the news service to issue a retraction.
News of the approval, though, comes to us courtesy of Reuters. The Amgen site, oddly enough, doesn’t have any mention. Perhaps, the press release is still in a drawer in Kevin Shearer’s desk? Not to worry. The official word will be out any moment. Kevin needs to celebrate any bit of good news he can find.
Steve Knows
At this point, Amgen will take anything that resembles even a shred of extra income. The company knew from the beginning that it would benefit a very small population and the income about the same, small.
We are sitting in a tight trading range, awaiting the supposedly heart throbbing Deno meeting on September 16, 2008. That report better have some extremely positive news, beyond what we already know. The traders and investors are looking at this news as another chance to make more money.
nick
The drug, developed by Amgen, is a monoclonal antibody that specifically binds to a protein, called epidermal growth factor receptor, or EGFR, often present on colorectal tumors. It received an accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor. It is biotechnology giant Amgen’s first drug aimed at curing cancer. Amgen’s other products help restore red and white blood cells that can be depleted during cancer treatment or as a result of disease.
“Colorectal cancer is the third most common cancer and the third leading cause of cancer mortality in the United States,” Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research said in announcing the approval. “This approval adds a treatment option for patients with an advanced stage of a disease that can be life-threatening.”
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nick
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