Our Review Summary
This news release from the FDA announces the agency’s approval of a new drug, dupilumab (to be marketed as Dupixent), for treating eczema, or atopic dermatitis. It briefly describes the type of clinical trials leading to the approval and identifies the possible harms that might arise from use of this injectable drug. It omits, however, any measurements showing how effective the drug is, referring to benefits only in general terms.
Why This Matters
Some estimates suggest as many as 18 million Americans suffer from moderate-to-severe eczema — and for them it is a miserable disease. A new medication that is potentially effective against this condition would therefore be welcomed. But the enormous cost of this drug, similar to others aimed at thwarting eczema, might play a major role in patient access to the treatment.
Criteria
Not Applicable
The FDA evaluates drugs without considering costs, which is why they are not discussed in this news release. We rate this one Not Applicable. We hope the FDA will also begin commenting on the projected cost of a drug and its cost-effectiveness.
In this case, costs are very steep. An NBC.com story on the approval which we also reviewed, predicts the drug will cost $37,000 annually. It’s unknown if Dupixent will be covered by health insurance.
Not Satisfactory
In terms of benefits, the release offers the following: “Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment.” But readers are left to interpret on their own what “greater response” and “a reduction in itch” mean.
The release would have been better if it had told readers how the improvement was measured and how many patients experienced improvement rather than using the term “overall.”
Satisfactory
The release gets an acceptable rating in this category since it mentions that the drug can cause serious allergic reactions and eye problems including conjunctivitis (pinkeye) and keratitis (inflammation of the cornea). It also cautions that people with asthma shouldn’t use the drug since it hasn’t been tested for safety in these patients.
The release should also have noted that regulators don’t know if there are any long-term harms associated with Dupixent use. None of the trials exceeded 16 weeks.
Satisfactory
The release describes who was studied and for how long, and offers a bare-bones description of the types of studies: “The safety and efficacy of Dupixent were established in three placebo-controlled clinical trials with a total of 2,119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s).”
The FDA doesn’t provide a link to the studies or their titles and where they were published. The release would be more complete had that information been included. It would help journalists and people with eczema and would be a significant improvement to FDA releases.
Satisfactory
The release does not engage in disease-mongering. Instead it offers a clear description of what eczema is and what causes the condition.
Not Satisfactory
There is no mention of who funded the research leading to the FDA approval, although many readers will assume it was supported by the manufacturer Regeneron.
Satisfactory
The release gets a borderline satisfactory for mentioning topical corticosteroids as an alternative treatment for eczema but neglects to mention that other pharmaceuticals are also now available for treating it.
Not Satisfactory
Whether or not this medication will be covered by insurance is a huge concern. Its high cost will affect how many people can access this new drug. Its availability should have been addressed in the release.
Satisfactory
It’s newsworthy whenever the FDA approves a new drug. This appears to be the first biologic, injectable treatment for eczema.
Satisfactory
The release does not use any unjustifiable language.
Total Score: 6 of 9 Satisfactory
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like