Source Pravda.Ru

Amgen's drug Nplate raises FDA's concerns over adverse reactions

The Food and Drug Administration is highly concerned about Amgen's drug Nplate designed to treat a blood-clotting disorder.

Nplate allegedly revealed a number of adverse reactions, from bone-marrow abnormalities to dangerous blood clots. Now FDA faces quite a difficult task of whether to approve the drug or not, and if it’s going to approve it under what conditions it should be used?

Amgen Inc. (NASDAQ: AMGN, SEHK: 4332), an international biotechnology company famous for its drugs against anemia, arthritis and neutropenia, uncovers its new experimental biotech drug and seeks for FDA’s approval. Nplate may help people with a disorder that causes the body to attack its own red blood cells necessary for blood-clotting.

Amgen’s studies proved that Nplate, actually genetically engineered version of the protein that encourages red blood cell production, increased significantly the level of platelets. Though the picture is not so bright. 14 of 204 patients showed adverse reactions. And it’s still unknown whether the risk of blood clots is higher, when a patient stops taking this drug.

In addition, FDA learned that about eight percent of patients taking Nplate developed a resistance to the drug.

Some analysts predict that in the end the drug will be approved as there are a lot of people who are resistant to other treatments.

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