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.
Russia has been developing an energy module on the basis of the megawatt-class nuclear power plant since 2010. The spaceship needs neither sunlight nor solar batteries
There are legitimate authorities in Donetsk and Luhansk republics now, with which Russia can implement the project of the economic integration of the Donbass
Austria does not intend to expel Russian diplomats because of the spy scandal