<a href=Amgen” height=”202″ src=”https://www.pharmaceutical-technology.com/wp-content/uploads/image-digitalinsightresearch/Archive/Main/Amgen.jpg” style=”padding: 10px” width=”269″ />

The European Medicines Agency (EMA) has accepted US-based drugmaker Amgen’s marketing authorisation application (MAA) for Kyprolis (carfilzomib) for Injection to treat patients with relapsed multiple myeloma who have received at least one prior therapy.

Kyprolis is a proteasome inhibitor developed to treat multiple myeloma. It is a product of Onyx Pharmaceuticals, a subsidiary of Amgen.

Onyx Pharmaceuticals president Pablo Cagnoni said: "Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing.

"We look forward to working with European regulators to potentially make this important medication available."

"Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing."

The MAA comprises data from the Phase III Carfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of Patients with Relapsed Multiple Myeloma (ASPIRE) trial, in addition to other relevant data.

Earlier, Kyprolis obtained orphan drug designation by the EMA in the European Union (EU). It also received approval in Argentina, Israel and Mexico.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Kyprolis received accelerated approval from the US Food and Drug Administration (FDA) to treat patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (IMiD).

The randomised Phass III ASPIRE trial assessed Kyprolis in combination with lenalidomide and low-dose dexamethasone, against lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens.

The study randomised 792 patients at sites in North America, Europe and Israel. Its primary endpoint was progression-free survival and secondary endpoints included overall survival, overall response rate, duration of response, disease control rate, health-related quality of life and safety.

Image: One of the many buildings at Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.