Recommendations for approval, approvable designations, Fast-track designations
PSG: Specialty Drug Trend Continues Upward
Higher costs per claim, coupled with an increased number of patients using specialty drugs, has contributed to higher spend.
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FDA Approves Oral JAK Inhibitor for Alopecia
Leqselvi is approved to treat adults with severe alopecia. One-third of patients in clinical trials experienced 80% scalp hair coverage at 24 weeks.
Nonsteroidal Drug for Duchenne Launches with a $700,000 Price Tag
Duvyzat was approved in March 2024 and works to reduce the inflammation and loss of muscle experienced by patients with Duchenne muscular dystrophy.
FDA Approves Second Biosimilar of Soliris
Epysqli is a monoclonal antibody that is approved to treat two rare conditions that break down red blood cells.
GoodRx to Offer Boehringer Ingelheim’s Humira Biosimilar
Boehringer Ingelheim’s high- and low-concentration adalimumab-adbm will be available through GoodRx for $550 for two-pack, which represents a 92% discount from the Humira list price.
FDA Sets Review Date for Cell Therapy for Post-Transplant Complication
If approved, tabelecleucel would be the first therapy specifically to treat Epstein-Barr virus related post-transplant lymphoproliferative disease. The FDA’s action date is Jan. 15, 2025.
