1. Scrip
  2. >>Therapy Areas
  3. >>Cardiovascular

Still Hope For Zetia Expansion After Negative Committee

 
• By Lisa LaMotta

An FDA Advisory Committee voted against an expanded approval for Merck & Co.'s cholesterol drug Zetia into a broader population. The negative vote may be a surprise to investors who thought the added label was a slam dunk, but anyone listening to the panel could’ve seen this negative vote coming.

The Endocrinologic and Metabolic drugs Advisory Committee voted 10 to 5 against expanding the label for Zetia (ezetimibe) to be...

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 Cardiovascular

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.

Novartis Upbeat Even With Entresto Expiry Looming

 
• By Kevin Grogan

Swiss major confident that new oncology drugs will fill revenue gap.

AstraZeneca’s Amyloidosis Drug Fails In Phase III But Subgroup Hopes Persist

 
• By Andrew McConaghie

Anselamimab was expected to complement Alexion's portfolio of amyloid therapies, but regulators will have to be convinced of its benefits to a patient subgroup in the CARES trial.

Bayer’s Kerendia Gains Blockbuster Indication For Heart Failure

 
• By Joseph Haas

New US approval in heart failure with preserved or mildly reduced ejection fraction should add to Kerendia’s earning power on top of chronic kidney disease indication.

More from Therapy Areas

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.

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By Manas Mishra

Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.

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.