Leo's Tralokinumab Poised For US Launch In 2021

The dermatology specialist said a BLA for the IL-13 blocker has been accepted by the US FDA for the treatment of atopic dermatitis.

SC2007_Second Place_1457882090_1200.jpg
Leo's tralokinumab is poised to be the second biologic to market for atopic dermatitis • Source: Shutterstock

Dermatology specialist LEO Pharma A& is preparing to launch the interleukin-13 inhibitor tralokinumab for atopic dermatitis in the US in 2021, where it will compete against a well-entrenched rival, Sanofi and Regeneron Pharmaceuticals, Inc.'s Dupixent (dupilumab). Leo announced on 9 July that the US Food and Drug Administration has accepted a biologics license application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis, with action expected in the second quarter of 2021.

A regulatory review in Europe is already underway, with an application accepted in June.

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 Dermatological

Ascletis Plans China Submission After Positive Denifanstat Phase III Acne Results

 

Once-daily oral FASN inhibitor denifanstat meets all endpoints in a Chinese Phase III trial for moderate-to-severe acne, paving the way for a regulatory submission in China.

Sanofi Plays It Safer With Blueprint Buy After Bumpy 2025

 
• By 

But the French major is still keen on early-stage M&A.

InflaRx Stock Sinks As Vilobelimab Fails Phase III Skin Trial

 
• By 

A study of the German biotech's intravenous complement factor C5a antibody for pyoderma gangrenosum was stopped for futility.

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By 

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

More from Therapy Areas

Vertex Heralds ‘Unprecedented’ Zimislecel Type 1 Diabetes Data

 
• By 

The off-the-shelf stem cell therapy shows sustained glycemic control and a high rate of insulin independence.

Obesity Treatment Could Go Global With Lilly’s Orforglipron

 

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.

Shigella Vaccine Pipeline And Why It Matters

 
• By 

A GSK-Bharat Biotech deal on a shigella vaccine candidate has cast a spotlight on the disease, which is the second leading cause of diarrheal deaths in children below five. Scrip looks at data from Pharmaprojects, WHO and other sources to highlight why a vaccine matters and what pharma is doing.