InDex Pharmaceuticals announces successful interactions with the PMDA for the clinical development of cobitolimod in Japan
16 August, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced that the company has received positive feedback from the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), regarding the clinical development plan for a future marketing authorization application for the company's TLR9 agonist cobitolimod, for the treatment of moderate to severe left-sided ulcerative colitis. The PMDA has accepted enrolment of Japanese ulcerative colitis patients in the second global phase III induction study, without performing specific Japanese studies prior to