Amgen and its subsidiary Onyx Pharmaceuticals have submitted filings for their multiple myeloma drug Kyprolis (carfilzomib) on both sides of the Atlantic.
The companies are seeking approval to market their drug for the treatment of patents with relapsed multiple myeloma who have received at least one prior therapy.
In the US, Kyprolis is already cleared under accelerated approval for use in patients with multiple myeloma who have already received at least two other treatments and whose disease has progressed; a supplemental New Drug Application has now been filed to support the conversion of this to full approval and expand target population.
In the European Union, Kyprolis has received orphan drug designation and the marketing application has been granted accelerated assessment.
Amgen’s Q4 beats expectations
Meanwhile, Amgen, the world’s largest biotech, posted a solid set of fourth-quarter results that topped expectations.
Excluding special items, earnings came in at $2.16 a share, overshooting the average $0.11 analyst forecast compiled by Bloomberg.
Revenue jumped 6.4% to $5.33 billion, given a leg-up by stronger-than-expected sales of Enbrel (etanercept), which were up 11% at $1.34 billion.
Amgen restated its 2015 forecast for adjusted earnings of $9.05-$9.40 per share and sales of $20.8-$21.3 billion.