Tirzepatide is filed at FDA and at EMA to treat type 2 diabetes.
Eli Lilly announced with its Q3 financial results that it has submitted a New Drug Application (NDA) to the FDA and a Marketing Authorization Application to the European Medicines Agency for tirzepatide for the treatment of adults with type 2 diabetes.
A Priority Review Voucher was applied to the NDA, leading to an anticipated review time of eight months from the date of submission according to current FDA priority review timelines. Several additional submissions are planned around the world before the end of 2021.
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Vanda Pharmaceuticals Inc. announced a win in its jet lag FOIA litigation against the FDA. On March 27, 2023 a federal court granted final judgment in favor of Vanda in its Freedom of Information Act ("FOIA") case requesting records created by the FDA during its review of Vanda's application seeking approval of a new use for its drug, Hetlioz (tasimelteon).
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with HER2-low unresectable or recurrent breast cancer after prior chemotherapy.The indication is for patients with HER2-low disease defined as immunohistochemistry (IHC) 1+ or IHC 2+/in situ hybridization.
Merck Inc., known as MSD outside of the United States and Canada, announced results from the Phase III NRG GY018 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) then continued as a single agent every six weeks for up to 14 cycles for the first-line treatment of patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either mismatch repair proficient (pMMR) or mismatch repair deficient (dMMR).