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  1. News & Events for Human Drugs

FDA approves first treatment for prurigo nodularis

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FDA has approved Dupixent (dupilumab) injection for the treatment of adults with prurigo nodularis (PN). This is the first FDA-approved treatment for PN. Dupixent is FDA-approved for multiple indications, including treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis. Dupixent comes as a single-dose pre-filled syringe with needle shield or as a pre-filled pen and is given as an injection under the skin. The patient’s health care provider determines the treatment duration for Dupixent to treat PN. 

Disease or Condition 

PN is a rare skin disease that causes hard, itchy lumps (nodules) to form on the skin. The itching can be intense, causing people to scratch themselves to the point of bleeding or pain. Scratching can also cause more skin lesions to appear. The disease affects approximately 87,000 adults per year according to the National Organization for Rare Diseases database. 

Effectiveness 

Safety and effectiveness of Dupixent to treat PN among adults were evaluated in two clinical trials, EFC16459 (PRIME) and EFC16460 (PRIME2). Each trial evaluated 300 mg of Dupixent administered every 2 weeks following an initial dose of 600 mg. The treatment lasted for 24 weeks. 

Effictiveness was mainly assessed by the proportion of subjects whose itchy skin (pruritus) improved by more than four points on the Worst Itch Numeric Rating Scale, the proportion of subjects who achieved score of 0 or 1 on Investigator’s Global Assessment PN-stage scale (the equivalent of 0-5 nodules), and the proportion of subjects who achieved a response on both scales at week 24.  

In the trials for the PN indication, the primary endpoint and key secondary endpoints were considered significant when compared to placebo. 

Safety Information 

The most common side effects of Dupixent include injection site reactions, herpes simplex virus infections, common cold, muscle pain, diarrhea, and throat pain. Dupixent can cause serious side effects, including allergic reactions, eye problems, inflammation of blood vessels, and joint aches and pain. It is not known if Dupixent is safe and effective in children with PN under 18 years of age.  

See full prescribing information for additional information on risks associated with Dupixent. 

Designation 

Dupixent received priority review for this indication. 

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