Arcutis’s Zoryve Succeeds In Second Phase III In Atopic Dermatitis

Immuno-dermatology specialist intends to submit the topical roflumilast to the US FDA during the first half of 2023, potentially adding an even larger indication to its approval for psoriasis.

Atopic dermatitis
Arcutis moves toward adding AD to the Zoryve label • Source: Shutterstock

With success in a second Phase III trial of its topical formulation of roflumilast in atopic dermatitis, Arcutis Biotherapeutics, Inc. moved closer to seeking a supplemental approval of Zoryve (roflumilast) in AD, which analysts said would be an even bigger market opportunity than the drug’s initial indication in plaque psoriasis.

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 Clinical Trials

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By 

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.

In Brief: Genmab To Seek FDA Nod For Epkinly In Lymphoma

 

Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By 

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By 

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

More from R&D

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By 

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By 

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

Moderna Punts On US Vaccine Policy Changes, Will Focus More On Cancer

 
• By 

On its Q1 earnings call, Moderna avoided criticizing policy changes affecting vaccines but de-emphasized its flu/COVID-19 vaccine for under-50 and prioritized cancer programs.