It's Official: Novartis SMA Gene Therapy Zolgensma Is World's Most Expensive Drug
The total cost of Zolgensma is more than $2m – in line with estimates – or $425,000 annually for five years if payers choose an annuity-like payment plan. Novartis is also negotiating value-based reimbursement agreements for infants treated with the one-time infusion.
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AveXis President David Lennon talked to Pink Sheet about quality enhancement at the gene therapy unit, a clinical trial hold for Zolgensma in Type 2 SMA, and expansion in gene therapy.
With top-line data showing efficacy in type 1 SMA patients, risdiplam may be able to obtain a label that would address significantly more patients than Novartis’ Zolgensma. Final efficacy data will show how drug’s efficacy compares to Biogen’s Spinraza.
Tropical diseases were not neglected by the Center for Biologics Evaluation and Research in 2019, producing three novel vaccines (which earned three priority review vouchers) and tilting the approval class toward expedited review programs.