Novartis (SWX: NOVN, NYSE: NVS)’s Chinese arm has announced that it has received approval from the National Medical Products Administration (NMPA) for its drug candidate, cemiplimab, to be used in the treatment of adults and children aged 12 and over with moderate-to-severe atopic dermatitis (AD). The drug, known as cemiplimab in China, has been approved for a range of indications in the United States, including the treatment of non-small cell lung cancer (NSCLC), and is now poised to address the needs of AD patients in China.
Cemiplimab is an interleukin-13 (IL-13) inhibitor that targets the IL-13Rα1/IL-4Rα heterodimer receptor complex, which plays a crucial role in the pathogenesis of AD. The drug has demonstrated significant improvements in clinical trials, with a 23.1% objective response rate (ORR) and a 44.2% proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0/1 with at least a 2-point reduction from baseline after 16 weeks of treatment. These results, along with its favorable safety profile, have positioned cemiplimab as a potential game-changer in the treatment of AD.
This approval comes on the heels of cemiplimab’s previous approval in China for the treatment of NSCLC, marking a significant expansion of Novartis’s portfolio in the country. The drug’s unique mechanism of action and its potential to provide long-term relief to AD patients without the need for frequent administration make it a promising addition to the treatment landscape. – Flcube.com
