FDA & EMA
On February 28, Regeneron and Sanofi co-announced that the FDA approved the marketing application for sarilumab (brand name: Kevzara) in treating adult patients with polymyalgia rheumatica who have an inadequate response to corticosteroids (CS) or are unable to tolerate corticosteroid reduction. It is the first and only biologics approved by the FDA to treat the disease. Sarilumab is an IL-6 fully humanized monoclonal antibody.
On February 28, Cytokinetics announced that it had received a complete response letter (CRL) from the FDA regarding its new drug application (NDA) for omecamtiv mecarbil, the understudied selective and small molecule cardiac myosin activator. The FDA believes that the existing data is insufficient to support the approval of omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF).
On March 14, Futura Medical announced that it had received review comments from the FDA on the De Novo application (a way of application for a medical device) for MED3000 in treating erectile dysfunction (ED), and thus the marketing program for this product would be deferred until the second quarter of 2023. Once approved, MED3000 will be the first over-the-counter (OTC) medicine approved for and indicated in the treatment of ED.
On March 16, the NMPA official website revealed that the darolutamide (brand name: Nubeqa) of Bayer for a new indication was approved for marketing. Upon this approval, it can be used in combination with docetaxel in treating patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide is an oral androgen receptor inhibitor (ARi) co-developed by Bayer and Orion.
On March 22, Cidara announced that the FDA approved the marketing of rezafungin (brand name: rezafungin) in treating candidemia and invasive candidiasis. Previously, the FDA has granted rezafungin qualified infectious disease product (QIDP), orphan drug, and fast track designation.
On March 22, Incyte announced that the FDA approved the marketing of retifanlimab (brand name: Zynyz) in treating adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). Retifanlimab is a humanized anti-PD1 monoclonal antibody. In 2019, Zai Lab and Incyte Company announced their licensing agreement on the development and commercialization of retifanlimab in Greater China.
On March 30, the EMA official website revealed that the marketing application for semaglutide (brand name: Wegovy) submitted by Novo Nordisk had been recommended and approved by the Committee for Medicinal Products for Human Use (CHMP) for weight management in adolescents aged 12 years and older. Wegovy was approved in the United States for adult weight loss indications in June 2021. On December 23, 2022, Wegovy was approved by the FDA to expand the applicability to adolescents aged 12 years and older based on positive results from the phase III STEP TEENS study. As the target users of Wegovy are expanding, its sales volume is expected to grow even further in 2023.
NMPA
On March 1, the NMPA official website revealed that Sino Biopharm's palbociclib capsules were approved for marketing. Palbociclib, the first approved CDK4/6 inhibitor in the world, can selectively inhibit CDK4/6, restore cell cycle control, and block tumor cell proliferation. The approved indication is locally advanced or metastatic breast cancer with hormone receptor (HR) - positive and human epidermal growth factor receptor 2 (HER2) - negative. The product should be used in combination with aromatase inhibitors as initial endocrine therapy for postmenopausal female patients.
On March 1, the NMPA official website revealed that Sino Biopharm's tedizolid phosphate tablets and tedizolid phosphate for injection were approved for marketing. Tedizol...
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