CALT - Everest's kidney disease drug Nefecon gets review in Singapore

2023-04-06 05:40:50 ET

Singapore's Health Sciences Authority (HSA) accepted to review Everest Medicines' application seeking approval of Nefecon to treat primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

The company expects to get approval of the new drug application (NDA) in Singapore this year.

The NDA acceptance in Singapore marks the second region, after Mainland China in November 2022, in which Everest has made a successful NDA filing as a first-in-disease therapy, the company added.

Everest expects the NDA in China, which is under priority review, to be approved in H2 2023.

"We also plan to submit NDAs for Nefecon in South Korea, Hong Kong and Taiwan regions this year," said Everest's CEO Rogers Yongqing Luo.

In February, Nefecon received a global innovative product on fast track (GIFT) designation in South Korea to treat primary IgAN

Everest has a license agreement with Sweden's Calliditas Therapeutics' ( OTCPK:CLTEF ) ( NASDAQ: CALT ) under which the China-based company has rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan, Singapore and South Korea.

IgA Nephropathy occurs an antibody called immunoglobulin A (IgA) builds up in the kidneys. This leads to inflammation which can hamper the kidneys' ability to filter waste from the blood.

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