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US Capitol Capsule: Barriers to PCSK9s use: What to expect

 
• By Donna Young

While Sanofi and Regeneron Pharmaceuticals said the FDA granted what the companies perceived as a "pretty broad label" for Praluent (alirocumab) – the first proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor approved in the US to lower low density lipoprotein cholesterol (LDL-C) when statins are not enough – the firms said they anticipated some barriers to the drug's use in the US.

While Sanofi and Regeneron Pharmaceuticals said the FDA granted what the companies perceived as a "pretty broad label" for Praluent (alirocumab) – the first proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor approved in the US to lower low density lipoprotein cholesterol (LDL-C) when statins are not enough – the firms said they anticipated some barriers to the drug's use in the US.

And what goes for Praluent also could be true for Amgen's Repatha (evolocumab), which is expected to also gain US...

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Scholar Rock Shows Muscle-Building PoC In Obesity

 
• By Jessica Merrill

The company said it intends to maintain a focus on rare neuromuscular disease with apitegromab but could consider partnering in obesity.

Lilly Looks For Muscle-Sparing Candidates In Pact With Juvena

 
• By Joseph Haas

Deal Snapshot: Including its internal efforts with bimagrumab, Lilly has been seeking a muscle-sparing therapy to complement GLP-1 obesity drugs, such as Zepbound.

Novo Nordisk Teams With Deep Apple On Non-Incretin Obesity Approach

 
• By Joseph Haas

Novo Nordisk will partner with privately held Deep Apple to study a novel, non-incretin target that could be better suited than GLP-1s for long-term obesity treatment.

Metsera’s Amylin Analog Stars In Obesity Phase I

 
• By Joseph Haas

Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.

More from Therapy Areas

Scholar Rock Shows Muscle-Building PoC In Obesity

 
• By Jessica Merrill

The company said it intends to maintain a focus on rare neuromuscular disease with apitegromab but could consider partnering in obesity.

Spyre Takes Aim At Roche And J&J In Inflammatory Diseases

 
• By Andrew McConaghie

The US firm was already looking to compete in ulcerative colitis, but now expands its ambitions by moving into rheumatoid arthritis as well.

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By Kevin Grogan

Wales-based group launches with $140m series A.