Roche’s Evrysdi Approved For SMA, Priced Below Competitors
Oral drug will rival Biogen, Novartis therapies
Executive Summary
Risdiplam’s efficacy across two clinical trials and oral dosing made it a credible threat before its US FDA approval, but its weight-based pricing falls below Biogen’s Spinraza and Novartis’s Zolgensma.
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EU Accelerated Assessment Tracker
Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
EU Accelerated Assessment Tracker
Another three marketing authorization applications will be fast-tracked through the centralized review process at the European Medicines Agency. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.
PTC Eyes Transition From Capital-Raising To Money-Making Company
With $1.1bn in cash plus revenue from its existing commercial products and royalties from Roche’s sales of newly approved Evrysdi to invest in R&D, PTC Therapeutics may achieve profitability in 2023.
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