In this segment of the HCPLive editorial team’s discussion with Lawrence Eichenfield, MD, Eichenfield was asked to respond to the US Food and Drug Administration’s (FDA) decision to provide a Complete Response Letter (CRL) to a supplemental Biologics License Application (sBLA) for dupilumab as a treatment for those with chronic spontaneous urticaria (CSU).¹

Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. Additionally, he serves as a professor of dermatology and pediatrics, and as vice-chair of the department of dermatology of UC San Diego’s School of Medicine.

This interview occurred on the day of the FDA’s decision not to approve dupilumab for CSU, on the floor of the 2023 Fall Clinical Dermatology Conference in Las Vegas.

“First of all, dupilumab has been an incredible breakthrough drug for its initial disease state, atopic dermatitis, and then for several others,” Eichenfield said. “They included prurigo nodularis eosinophilic, esophagitis, nasal polyposis. So there's this list of things that have been approved for it, and there was a hope that the chronic spontaneous urticaria label would go along with it.”

Eichenfield commented that he believes the FDA’s response letter is essentially asking for more data on efficacy over time.

“It just wasn't as easy as it was to get these other indications,” he said. “Urticaria is a big issue. Historically, urticaria wasn't even listed as a comorbidity of atopic dermatitis. So, I don't know if people notice, but it got snuck into the comorbidity list in the recent AAD guidelines of adults, and we do see a lot of overlap. And then we have urticaria on its own, sometimes taken care of by dermatologists but often taken care of by allergists.”

Eichenfield added that he would have appreciated the ability to have this drug that dermatologists are already so comfortable with expanding over to that particular condition.

“It's not over yet, but they have slowed down the approval process,” Eichenfield said. “What was in my read of the information in the media release was that it doesn't seem that there's a safety concern, it's just about getting more more efficacy before they give approval.”

Later, Eichenfield was also asked about advice or guidance that he would offer to healthcare professionals who may have been considering or using dupilumab off-label for CSU in light of the FDA's response.

“I think my usual advice is that if you're considering off-label, you want to get a sense of your comfort level with a drug,” he explained. “If there are safety issues with the drug, and then figure out what the alternatives are. I'd say the same in this particular case. I think we have this expansive knowledge now of dupilumab and have a real sense of the safety. So it's certainly an option that that people have, as compared to other options.”

For further information, view Eichenfield’s full conference interview segment above.

The quotes used in this summary were edited for clarity purposes.

References

1. ^{Kunzmann K. Regeneron, Sanofi Receive CRL for Add-On Dupilumab sBLA for Chronic Spontaneous Urticaria. HCPLive. October 20, 2023. Date accessed: October 20, 2023. https://www.hcplive.com/view/fda-dupilumab-chronic-spontaneous-urticaria.}