Doubts Over DBV's Future As US FDA Rejects Peanut Allergy Patch

Development Of Viaskin Peanut Not Smooth

The French company's hopes of joining Aimmune's Palforzia on the peanut allergy market soon have been shattered after US regulators issued a complete response letter to its Viaskin Peanut patch. A lot now depends on how much work DBV will have to do to satisfy the FDA.

Allergy
There are 1 million children with peanut allergy in the US • Source: Shutterstock

Analysts have been weighing up the future prospects for DBV Technologies now that the already rocky road for approval of the French biotech's peanut allergy patch has turned to rubble after rejection from the US Food and Drug Administration.

The agency has issued a complete response letter regarding a biologics license application (BLA) for Viaskin Peanut, DBV's once-daily epicutaneous immunotherapy (EPIT) patch to treat peanut allergies in children aged...

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 Immunological

GlycoEra’s Series B Cash Will Fund Efforts To Take On FcRn Inhibitor Class

 
• By 

GlycoEra unveiled a $130m series B financing, saying the proceeds would enable it to take its first clinical candidate through proof-of-concept in autoimmune diseases.

Merck KGaA Plans Phase III For Enpatoran After Mixed Phase II Lupus Data

 

The Phase II study testing the novel TLR7/8 inhibitor met the primary endpoint in a cohort of patients with cutaneous lupus erythematosus and systemic lupus erythematosus with rash, but did not in patients with SLE.

Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

 

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

More from Therapy Areas

Progress In The Effort To Improve Outcomes In SCLC

 

Several drug makers are working to bring new advances to small-cell lung cancer, a fast-growing cancer with limited treatment options.

GSK’s Nucala Set For Dupixent Face-Off After FDA COPD Nod

 
• By 

The UK major's asthma drug gets a key expanded approval.

Merus Bispecific Impresses In Head And Neck Cancer

 

Updated Phase II results from petosemtamab have impressed ahead of ASCO, outshining Keytruda monotherapy and its bispecific rival from Bicara.