FDA’s new drug approvals in August include a Dupixent competitor, a targeted glioma therapy, and more 

FDA approved at least seven new therapies in August, ending a summer lull. The newly approved products include the first IL-31 mAb and competitor to Dupixent in rare skin disease prurigo nodularis; plus Gilead’s PPARδ agonist from its CymaBay acquisition, and a pair of cancer therapies targeted to specific mutations. 

IL-31 receptor mAb Nemluvio nemolizumab from  Galderma Group AG (SIX:GALD) achieved first-in-class status in the U.S. when FDA approved the therapy for prurigo nodularis. Nemluvio is the second treatment approved for the rare skin condition after IL-4 and IL-13 inhibitor Dupixent dupilumab from Sanofi (Euronext:SAN; NASDAQ:SNY). In Phase III OLYMPIA 1 and OLYMPIA 2 trials, 16 weeks of treatment respectively led to 56% and 49% of patients on Nemluvio experiencing at least a four-point reduction in itch intensity, versus 16% (p<0.001) in both studies’ placebo groups. Those findings are similar to Dupixent’s data. In Phase III PRIME trial, Dupixent led to at least a four-point reduction in itch in 44% of patients vs. 15.8% for placebo at week 12 (p<0.001), rising to 60% vs. 18.4% (p< 0.001) of patients at week 24. ...