US FDA approval tracker: July 2022

For companies that did not receive approval decisions in July, as expected, investors will hope that the old adage that no news is good news rings true. After the FDA provided proposed labelling in June the wait continues for Axsome’s AXS-05 in major depressive disorder. The verdict was originally scheduled for nearly a year ago and was first delayed by deficiencies. Neither has any update emerged on Akeso and Sino’s anti-PD-1 MAb penpulimab, which had an assumed first-half timing. Beigene, like Akeso, is based in China and review of its own anti-PD-1 MAb tislelizumab was postponed because Covid-related travel restrictions delayed inspections. Several drugs did manage to make it across the FDA line, though, including two dermatology thumbs-ups. Arcutis’s Zoryve, a topical PDE4 inhibitor, is now approved in plaque psoriasis, and Incyte’s Opzelura, a topical version of ruxolitinib, the active ingredient in Jakafi, became the first FDA-approved product for repigmentation in vitiligo.

The supplemental table has been updated to include the paediatric approval of Stelara.