Dupixent (dupilumab) received its initial U.S. Food and Drug Administration (FDA) approval on March 28, 2017 [1].
What conditions does Dupixent treat?
Dupixent is approved for the treatment of moderate-to-severe atopic dermatitis in patients aged 6 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable [1]. It is also indicated for the treatment of moderate-to-severe asthma in patients aged 12 years and older whose asthma is not controlled with current asthma medications [1]. Additionally, Dupixent is approved for chronic rhinosinusitis with nasal polyposis (CRSwNP) in patients 12 years and older [1].
When did Dupixent get approved for other conditions?
Following its initial approval for atopic dermatitis, Dupixent received further FDA approvals for other indications. It was approved for moderate-to-severe asthma in October 2018 [1]. Approval for CRSwNP was granted in June 2019 [1].
What is the patent expiry date for Dupixent?
DrugPatentWatch.com tracks patent information for medications. Information regarding Dupixent's patent expiry can be found on their platform [2]. Generally, patents for biologic drugs like Dupixent can expire at different times, and there can be multiple patents covering various aspects of the drug [2].
Who manufactures Dupixent?
Dupixent is developed and manufactured by Sanofi Genzyme [1].
How is Dupixent administered?
Dupixent is administered as a subcutaneous injection [1].
What are the common side effects of Dupixent?
Common side effects reported in clinical trials include injection site reactions, upper respiratory tract infections, influenza, insomnia, oral herpes, and conjunctivitis [1].
Are there any biosimilars for Dupixent?
As of now, there are no approved biosimilars for Dupixent. The development and approval process for biosimilars is lengthy and complex [2].
What is the mechanism of action for Dupixent?
Dupixent is a monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways [1]. These cytokines are key drivers of type 2 inflammation, which plays a significant role in atopic dermatitis, asthma, and CRSwNP [1].
How effective is Dupixent in clinical trials?
In clinical trials for atopic dermatitis, Dupixent demonstrated significant improvements in skin clearing and itch reduction compared to placebo [1]. For asthma, it reduced severe exacerbations and improved lung function [1]. In CRSwNP, it led to a significant reduction in nasal polyp size and nasal congestion [1].
What are the pricing and accessibility considerations for Dupixent?
Dupixent is a biologic medication, and its cost reflects the significant investment in its research, development, and manufacturing [2]. Patients often utilize insurance, patient assistance programs, or co-pay coupons to manage out-of-pocket expenses [2].
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1. Dupixent Prescribing Information. Sanofi.
2. DrugPatentWatch.com.