Drug Development, New Products

Kyowa Kirin gets some added love from the FDA, winning their second drug OK in 4 months

This is a good year for Kyowa Kirin.

The company touts itself as a Japanese-based drug group with a global focus, and they got a major assist on that score from the FDA on Wednesday with an approval for their cancer drug mogamulizumab. This OK follows close on the heels of another FDA OK for burosumab, a rare disease drug expected to make a significant mark with their partners at Ultragenyx.

Like burosumab, mogamulizumab was dubbed by regulators as a “breakthrough” therapy deserving VIP treatment. To be sold as Poteligeo, the CCR4 drug is designed to treat two rare forms of non-Hodgkin’s lymphoma: mycosis fungoides and Sézary syndrome.

Researchers for Kyowa Kirin came up with a median progression-free survival rate of 7.6 months for the drug, compared to 3.1 months for chemo — that easily qualifies for an accelerated approval at the FDA, which has been speeding the tempo considerably under the urging of Richard Pazdur and now commissioner Scott Gottlieb as well.

A little more than three months ago Kyowa Kirin and Ultagenyx won a green light for burosumab, a drug expected to rise to blockbuster status after being priced at $200,000 for an inherited form of rickets (weakening of the bones in children).

“Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma and this approval fills an unmet medical need for these patients,” said Pazdur in a statement.


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