Broad Enough? Sponsors Pleased With Narrower Praluent Label
This article was originally published in The Pink Sheet Daily
Executive Summary
Indication for cholesterol-lowering drug is narrower than Sanofi and Regeneron originally sought, but firms still see it as broad. Target patient population is estimated at 8-10 million patients, but sponsors are quick to say the number of actual users will be funneled down.
You may also be interested in...
Praluent Injunction Goes Unmentioned At PCSK9 Patent Case Appeal
Three-judge US federal appellate panel focuses on evidentiary rulings and patent validity in the dispute between Repatha marketer Amgen and Sanofi/Regeneron; lower court’s permanent injunction barring sales of Praluent did not come up at oral arguments.
Can Cholesterol Drug Sponsors Make The Case For Statin Intolerance?
Amgen's FOURIER outcomes study of Repatha supports LDL-lowering in high risk patients, but price may have to come down dramatically to spur wide use of the PCSK9 inhibitors with the subjective condition of statin intolerance.
Sanofi’s Praluent Closes Gap On Repatha In Europe, As GSK Gets Green Light For World’s First Malaria Vaccine
Europe’s CHMP grants positive opinions for Sanofi’s Praluent and GSK’s not-for-profit malaria vaccine Mosquirix at July meeting; other products recommended include Shire’s Intuniv, Merck’s Zerbaxa, Basilea’s Cresemba and Keryx’s Fexeric.