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This summer, Amgen and Regeneron Pharmaceuticals/ Sanofi will battle it out in the competitive cholesterol market. Repatha and Praluent, respectively, are expected to be approved by the FDA this summer.
Amgen’s Repatha and Praluent, from Regeneron and Sanofi, are both expected to be approved by FDA this summer. Both target the same protein and have been shown to sharply lower LDL in high-risk patients, according to Reuters.
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While Amgen, Regeneron and Sanofi have not revealed the pricing of the new drugs, some industry experts suggest that low-dose Praluent will be priced “significantly below Repatha to make it more attractive to health insurers who have become increasingly aggressive about keeping medication costs down”, Reuters reported.
Sanford Bernstein analyst Geoffrey Porges predicts that lower-dose Praluent will cost $5,000 a year, with the higher dose at $10,000, according to Reuters. Porges estimated that Repatha could cost $10,000 per year for both the biweekly and monthly versions.
In addition, Amgen's high-dose monthly injection could be seen as more convenient and might appeal to doctors because of its higher potency. Still, Regeneron and Sanofi could have a significant pricing advantage with their low-dose option.
“Amgen's high-dose injections could be appealing in light of recent clinical data that has shown that keeping LDL very low can better protect against heart attack and stroke in high risk patients. Trial data has shown that both drugs produce greater LDL reductions in higher doses,” Reuters reported.
FDA is expected to decide on approval for Praluent by July 24 and on Repatha by Aug. 27. The agency has convened expert panels on June 9 and 10 to review both drugs and could also issue a joint decision.