Fewer Drug Launches In 2022, But Standouts Among Them
Lilly's Mounjaro and Roche's Vabysmo appear on track to be fast blockbusters in a year that saw the fewest drug launches since 2016.
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Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.
The US commercial strategy for the PCSK9 inhibitor Leqvio was tied to reimbursement under Medicare Part B, but it hasn't developed the way Novartis envisioned.
With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals
US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.