1. Scrip
  2. >>Therapy Areas
  3. >>Alimentary/Metabolic

Repatha review not quite Praluent mirror; dosing stands out

 
• By Donna Young

While it may appear at first glance the FDA's review of Amgen's proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor Repatha (evolocumab) mirrors in many ways what the agency said late last week about Sanofi's and Regeneron Pharmaceuticals' experimental drug in the same class, Praluent (alirocumab), regulators have identified some differences – mostly notably around the dosing of the products.

While it may appear at first glance the FDA's review of Amgen's proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor Repatha (evolocumab) mirrors in many ways what the agency said late last week about Sanofi's and Regeneron Pharmaceuticals' experimental drug in the same class, Praluent (alirocumab), regulators have identified some differences – mostly notably around the dosing of the products.

But it was apparent Dr James Smith, deputy director of the FDA's Division of Metabolism and Endocrinology Products, enjoyed the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Alimentary/Metabolic

Viking Rapidly Advancing Oral And Injectable VK2735 For Obesity

 
• By Joseph Haas

In its Q2 update, Viking reported that Phase III trials of subcutaneous VK2735 are under way, and that it expects Phase II data for an oral formulation before year’s end.

Obesity Beyond GLP-1s: Amylins – The Next Frontier

 
• By Aakash Babu

In this series of articles, we look at different mechanisms of actions beyond GLP-1s that could determine the obesity drug landscape in the coming years. First on our list – amylin receptor agonists, which analysts expect to grow into a $50bn market opportunity.

In Brief: Kezar Plots Lupus Revival For Zetomipzomib As FDA Lifts Hold On Hepatitis Trial

 
• By Manas Mishra

The go-ahead to resume a trial for its only drug candidate, zetomipzomib, in hepatitis could give Kezar a glimmer of hope of reviving another halted study in lupus nephritis.

Kailera Eyes Global Obesity Market With Hengrui’s Phase III Dual Agonist

 
• By Joseph Haas

With China’s Hengrui reporting successful Phase III data for its dual GLP-1/GIP agonist, licensee Kailera is readying plans to demonstrate better efficacy than current obesity drugs.

More from Therapy Areas

GSK’s Blenrep US Setback Could Go From Bad To Worse

 
• By Sushmita Panda

With a US approval any time soon now looking unlikely, analysts are revising Blenrep’s peak sales guidance downwards.

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 
• By Andrew McConaghie

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
• By Alexandra Shimmings

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.