Kyowa Hakko Kirin has announces that its marketing authorisation application (MAA) for mogamulizumab, for the treatment of cutaneous T-cell lymphoma (CTCL) in adults who have received at least one prior systemic therapy, has been validated by the European Medicines Agency (EMA) and is now under review.
This MAA is based on the data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study, the largest global randomised clinical trial of systemic therapy in CTCL.
“This is a significant milestone for our subsidiary, Kyowa Kirin Pharmaceutical Development,” said Mitsuo Satoh, Ph.D., executive officer, vice president head of R&D Division of Kyowa Hakko Kirin. “I believe mogamulizumab has the potential to be an advance in therapy for patients with CTCL and we will keep working to make it available to patients as soon as possible.”
Mogamulizumab was first approved in Japan 2012 for other haematological malignancies and in 2014 for use in CTCL. Kyowa Hakko Kirin has also initiated discussions with regulatory authorities concerning plans for marketing authorisation applications for mogamulizumab in CTCL in other countries.
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
Ema validates kyowa hakko kirin\\\'s maa for mogamulizumab to treat ctcl
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