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Long Wait Ahead For Novartis's Leqvio In US

German Launch In February, UK Maybe Q3

 
• By Kevin Grogan

The timeline for a US resubmission of the closely watched PCSK9-targeting cholesterol treatment could be either Q2 or Q3 and approval will depend on whether the FDA needs to make a physical inspection of an Italian facility.

delays
US patients won't be getting Leqvio any time soon • Source: Shutterstock

Any hopes for an imminent Europe-wide launch of Novartis AG's Leqvio or a speedy resolution of the issues that have held up US approval of the closely watched twice-yearly cholesterol drug have been cooled by CEO Vas Narasimhan.

Speaking as Novartis unveiled its fourth quarter and full-year 2020 results, Narasimhan addressed the surprising complete response letter (CRL) for...

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• By Sushmita Panda

As it races AstraZeneca’s baxdrostat to market, Mineralys plans to file an NDA later this year, backed by strong efficacy and safety data across four trials.

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The Phase III trial met the primary endpoint of time to clinical worsening in patients newly diagnosed with pulmonary arterial hypertension.

Obesity Treatment Could Go Global With Lilly’s Orforglipron

 
• By Andrew McConaghie

The company’s oral GLP-1 candidate has reassured on its safety at the American Diabetes Association meeting, convincing analysts it will open up new global markets.

Lilly Agrees To Acquire PCSK9 Base-Editing Partner Verve

 
• By Joseph Haas

Instead of opting in on Phase II-ready PCSK9-targeted VERVE-102, Lilly will buy its partner for up to $1.3bn. Analysts call the deal a bargain for Lilly, but fair to Verve.

More from Therapy Areas

Battle For Obesity Market Shifts Gears in India: Will Wegovy Trump Mounjaro?

 
• By Anju Ghangurde

Novo Nordisk debuts Wegovy in India, gears for pole position in obesity. The Danish group’s leadership doesn’t appear too perturbed about the head start for Lilly’s Mounjaro or the imminent arrival of generic semaglutide next year.

Amgen’s MariTide Data Not The Hit Investors Sought

 
• By Joseph Haas

MariTide demonstrated solid 52-week weight loss in a Phase II update, but high rates of vomiting. Amgen is adjusting dosing in Phase III to seek a better tolerability profile.

Industry’s Vaccines Pipeline In A Changing Regulatory Landscape

 
• By Jessica Merrill

More than a dozen vaccines for infectious diseases are in Phase III development across the industry, as the US regulatory environment brings increased uncertainty.