Resources for Food and Drug Administration (FDA)

Amgen Gets Its FDA Response

www.fool.com

Amgen (Nasdaq: AMGN) investors can finally breathe a little sigh of relief after the biopharma giant announced on Friday that the Food and Drug Administration had finally approved its blood disorder drug Nplate for marketing.

After having its Nplate marketing application decision delayed twice by the FDA, first in April and a second time in July, Amgen finally got the go-ahead to sell Nplate as a treatment for a rare chronic blood platelet disorder called chronic immune thrombocytopenic purpura (ITP).

Amgen estimates that there are 60,000 patients in the U.S. being treated with steroids and other drugs for thrombocytopenia and 140,000 total, counting Europe. None of these treatments are very effective, and Amgen will have a good opportunity to carve out a large market for itself, depending on how another potential thrombocytopenia treatment, Promacta, from GlaxoSmithKline and Ligand Pharmaceuticals, fares with the FDA.

View the Resource

Share or bookmarklet this web page at: