Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Earlier this week, Amgen Inc (AMGN) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its PCSK9 inhibitor, evolocumab (AMG 145) for the treatment of high cholesterol. Evolocumab works by inhibiting PCSK9, a protein that lowers the liver’s ability to remove “bad” cholesterol from the blood.
The application includes data from 10 phase III studies. Amgen has been consistently presenting positive data on evolocumab.
The submission of the EU marketing application comes on the heels of the submission of a Biologics License Application (BLA) to the FDA for evolocumab. We believe evolocumab has huge market potential. However, other companies including Sanofi (SNY) and Regeneron (REGN) are also developing PSCK9 inhibitors.
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Meanwhile, Amgen also announced that it is seeking EU approval for its oncology candidate, talimogene laherparepvec, for the treatment of adults with melanoma that is regionally or distantly metastatic.
We note that Amgen submitted the BLA for talimogene laherparepvec in July this year in the U.S. Amgen’s regulatory application is the first MAA for an oncolytic immunotherapy in the EU.
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The company recently received priority review status for ivabradine for the treatment of chronic heart failure. Meanwhile, Amgen is also exploring the world of biosimilars. The company is working on the worldwide development and commercialization of oncology antibody biosimilar medicines. Amgen expects to launch six new biosimilars from 2017.
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