Nxera Pharma’s Quviviq approved in Japan for insomnia

Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma (TYO: 45650.

The approval of Quviviq, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data including from a dedicated Japanese Phase III trial. Plans to make Quviviq available as soon as possible to insomnia patients in Japan are underway, said Nxera, formerly known as Sosei Group or Sosei Heptares.

Daridorexant is approved in the US and Europe and marketed in these territories under the brand name Quviviq by Swiss biotech Idorsia (SIX: IDIA) Idorsia Pharmaceuticals. Nxera Pharma has the Japanese and APAC (ex-China) rights for daridorexant following its acquisition of Idorsia Pharmaceuticals Japan Ltd and Idorsia Pharmaceuticals Korea Co in 2023.