Wild Ride For Immunology? New Mechanisms, Big Indications Up For US FDA Approval In 2022
Major R&D efforts in immuno-dermatology produced multiple novel candidates in atopic dermatitis and psoriasis, while alopecia areata and vitiligo might see first therapies and JAK safety and COVID-19 logjams resolve.
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Concert’s deuterated ruxolitinib analog is potentially third in line to market for alopecia areata, behind Lilly’s Olumiant and a Pfizer JAK3 inhibitor, but may be demonstrating a best-in-class profile.
Keeping Track: Marinus’ Ztalmy Continues US FDA’s Orphan Streak; AZ Gets Adjuvant Nod For Lynparza, Fasenra CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Physician response to FDA’s label change limiting Rinvoq to second-line-plus has been as expected, AbbVie said. Humira passed the $20bn sales threshold in 2021, but US biosimilar competition is one year away.