Review Cost For Sanofi/Regeneron’s PCSK9 Inhibitor Remains Uncertain
This article was originally published in The Pink Sheet Daily
Even after paying BioMarin $67.5 million for the voucher itself, the firms still don’t know how much FDA will charge for a chance to get Praluent to market faster.
You may also be interested in...
Draft guidance says sponsors remain eligible for rare pediatric disease priority review voucher even if they enroll also adults in clinical trials.
Formula was changed to better calculate the cost of a priority review, FDA says.
Companies’ decision to purchase and redeem BioMarin’s priority review voucher for their PCSK9 inhibitor alirocumab sets the first public benchmark for a voucher’s value and shows the potential advantages to be gained for sponsors in a race to market.