Amgen Inc. (NASDAQ:AMGN) received encouraging news with the European Commission (EC) approving a variation to the company’s marketing authorization for Kyprolis to include its use in combination with dexamethasone alone for the treatment of adults with multiple myeloma who have received at least one prior therapy.
EU approval was largely expected as the Committee for Medicinal Products for Human Use had issued a favorable opinion this May.
We note that this is the second approval for Kyprolis by the EC in less than a year. In Nov 2015, Kyprolis had gained approval in the EU in combination with Celgene Corporation’s (NASDAQ:CELG) Revlimid (lenalidomide) and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy, based on the ASPIRE study data.
The latest approval in the EU follows the FDA approval of a supplemental new drug application for Kyprolis earlier this year, based on the ENDEAVOR study data. In Jan 2016, Kyprolis’ accelerated approval was converted to full approval in the U.S. In addition, the FDA expanded Kyprolis’ label to allow its use as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
We remind investors that Kyprolis became a part of Amgen’s portfolio following its acquisition of Onyx. The drug has registered total sales of $512 million in 2015. Kyprolis’ label expansion would expand the patient population and increase its commercial potential significantly.
Other approved drugs for the treatment of multiple myeloma include the recently approved AbbVie Inc. (NYSE:ABBV) /Bristol-Myers Squibb Company’s (NYSE:BMY) Empliciti among others.
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