Bristol’s Mavacamten Shows Consistent Efficacy, Safe Use In Obstructive HCM At ACC

US FDA Decision On First Indication Due On 28 April

Long-term results from the EXPLORER-HCM extension study are consistent with the pivotal trial in obstructive hypertrophic cardiomyopathy, while data from VALOR may support a supplemental filing.

Heart shaped pills on a black background
Oral pill mavacamten is pending US FDA approval at the end of April • Source: Alamy

Bristol Myers Squibb Company has high expectations for its first-in-class cardiac myosin inhibitor mavacamten in hypertrophic cardiomyopathy (HCM), with peak annual sales predicted at more than $4bn. The company presented data at the American College of Cardiology (ACC) Scientific Sessions on 2 and 3 April in obstructive HCM (oHCM) that may help BMS make the case for strong commercial use of the drug based on safety and efficacy in a long-term study and in patients with more advanced disease.

Bristol’s multibillion-dollar sales estimate for mavacamten is based on multiple indications. The US Food and Drug Administration is reviewing 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

More from Cardiovascular

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 

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 

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

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

 

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 

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

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By 

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 

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.

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
• By 

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.