1. Scrip
  2. >>New Products

Revance Wins First Daxxify Therapeutic Indication, Plans Limited Initial Rollout

Longer-Lasting Toxin May Have Advantage In Cervical Dystonia

 
• By Mandy Jackson

Similar to its post-approval strategy in aesthetics less than a year ago, Revance will initially target a small number of doctors as it Daxxify to market in the US for cervical dystonia with a broader launch in 2024.

Woman having Neck and Shoulder pain
In cervical dystonia, neck muscles contract involuntarily • Source: Shutterstock

Revance Therapeutics, Inc. has won US Food and Drug Administration for Daxxify (daxibotulinumtoxinA-lanm) in the treatment of cervical dystonia (CD) – its second indication overall, but its first therapeutic use. The product, initially approved as an aesthetic medicine to reduce the appearance of glabellar lines, has the potential to best market leader Botox (onabotulinumtoxinA) in CD given its longer-lasting efficacy in a disease where neuromodulator benefits often wear off too soon for retreatment.

Nashville, TN-based Revance announced the FDA approval in CD on 14 August, 11 months after its first approval for glabellar...

Welcome to Scrip

Create an account to read this article

Already a subscriber?

More from New Products

Insmed Targets $5bn-Plus Market With Brinsupri For Bronchiectasis

 
• By Mandy Jackson

The US FDA approved Insmed’s second product, the DPP1 inhibitor Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis. The company launched the drug immediately with a list price of $88,000 per year.

Boehringer Scores First Approval For Targeted Oral Drug In HER2-Mutant NSCLC

 
• By Alaric DeArment

The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.

Pipeline Watch: Five Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

PTC Projects Confidence In Sephience Launch With Royalty Buyback

 
• By Manas Mishra

The company will start shipping its newly launched phenylketonuria drug within two weeks and has bought back global net sales obligations for the treatment.

More from Scrip

Xenon Nears Phase III Readout For Potential Epilepsy And Depression Blockbuster

 
• By Andrew McConaghie

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

Stock Watch: Sanofi And Merck Temper Big Pharma Q2 Earnings Cheer

 
• By Andy Smith

The investor enthusiasm that greeted initial second-quarter pharma earnings announcements was dampened by the results from Sanofi and Merck & Co. Sanofi was particularly punished by investors despite overall growth, while Merck’s revenue fall was probably baked into expectations.

Japan Results Roundup: Reduced Forex Impact, Uncertain US Tariff Outlook

 
• By Lisa Takagi

Most major Japanese firms report generally positive fiscal first quarter results, led by mainstay growth and despite lower currency effects. But the future impact of any US pharma tariffs remains an overhang.