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Detailing Potential Dermatology Drug Approvals from AAD 2022

Author(s):

Dr. Raj Chovatiya provides updates from AAD on some pending and potential FDA approvals for several dermatology therapies.

The American Academy of Dermatology (AAD) 2022 Annual Meeting has been replete with important new data on treatments for a variety of skin diseases including atopic dermatitis, vitiligo, prurigo nodularis, and more.

Oftentimes, conferences such as AAD have so much exciting data that it can be overwhelming.

Raj Chovatiya, MD, PhD, Assistant Professor at the Department of Dermatology, Northwestern University Feinberg School of Medicine, spoke with HCPLive of some of the potential approvals for dermatological therapies like topical ruxolitinib for vitiligo and bimekizumab for psoriatic disease, among many others.

HCPLive: Topical ruxolitinib was approved for use in patients with atopic dermatitis, but new 52-week data found that pproximately 3 in 10 patients with vitiligo treated with ruxolitinib cream achieved ≥90% improvement on facial vitiligo regimentation. Does an FDA approval seem imminent?

Dr. Chovatiya: Topical ruxolitinib is one of the new exciting therapies we have for immune mediated inflammatory disease, and topical ruxolitinib was recently approved a few months ago for the treatment of atopic dermatitis in people with mild to moderate disease. The way in which it works is it inhibits JAK protein family, in particular it looks like more in the realm of JAK1 and JAK2. Now, this is really exciting because it's the first topical JAK inhibitor we've had for this disease, but it looks like there's going be more uses for topical ruxolitinib than even atopic dermatitis, so and some really new exciting data that's been presented.

It looks like vitiligo may actually have a new therapy, a disease that's really been screaming for it just because what we have now doesn't work that great for our patients. So topical ruxolitinib really appears to do good work in repigmenting areas that have lost that pigment in the case of vitiligo. This is one of those approvals I think is imminent and is going to be great for us in the clinic.

HCPLive: Dupilumab has seen many indications for atopic dermatitis, from adults to adolescents. Could you speak to how it may be nearing approval for pediatric populations?

Dr. Chovatiya: dupilumab is one of those medications that's really changed the game for the way we think about moderate to severe atopic dermatitis. Dupilumab a biologic therapy, it's a monoclonal antibody that binds to the shared IL-4 receptor alpha subunit that's used by IL4 and IL-13. For signaling. These are 2 really important signals in what we call type-2 inflammation. Over time, we've seen approvals for dupilumab go from adults, to adolescents, down to kids, and most exciting of all, we're going to be getting approvals very soon down to 6 months of age.

This is huge considering we know what a burden atopic dermatitis is, particularly amongst our young kiddos, were the flares, the itch, lack of sleep, and the quality of life concerns are so hard on both patients and caregivers. But this isn't the only one coming through soon. We have exciting new data about other disease states like prurigo nodularis, chronic urticaria and even more. So it looks like we're going be having even more stories to tell about dupilumab.

HCPLive: Both deucravacitinib and bimekizumab have had promising data for the management of psoriatic disease. Could you speak to the function of these drugs and what might be in store for them regarding FDA approval?

Dr. Chovatiya: So you might have thought that the psoriasis story was completely done, but we still have new, impressive, incredible therapies probably heading to the toolbox near you.

So one of those is world do deucravacitinib, which is a TYK2 inhibitor. This is 1 of the 4 members of the JAK protein family, and this one really specifically seems to function in a part of that pathway that's important for IL- 17 in psoriasis and all these things we think about that disease. Now what's exciting is that this is an oral therapy, an area where we really have not had much going on for psoriasis. Largely we’ve been thinking about biologic molecules and not really oral small molecules. So this is going to be another great choice for patients to give them flexibility for their disease. But we're not done with biologics, either, and probably the next biologic we'll see for psoriasis is bimekizumab. This is an IL-17 molecule, which means that it's really going to work on one of those important pathways not only for psoriasis, but psoriatic arthritis as well.

The data looks to work quickly, it looks to be efficacious, and largely safety seems to be pretty good all around. So we're seeing a lot more excitement in psoriasis than we were expecting, even decades after we saw our first biologic.

HCPLive: What have been some of your main takeaways from AAD in regards to potential drug approvals and promising new data?

Dr. Chovatiya: So I think that one of the big themes of AAD this year has been atopic dermatitis. We've been starving for it and we're seeing a lot of work in the oral JAK inhibitors to take deeper dives into understanding some of that safety, efficacy and long-term data.

What we're seeing is incredibly promising for our patients with moderate to severe disease, and it's really looking like these medications are going to be really an important tool in the armamentarium for treatment. But that's not the only place we're seeing things.

Dupilumab-also approved for atopic dermatitis-looks like it has some impressive data across a variety of other disease states that we may not have necessarily thought about that much because there were never any approved therapies. Prurigo nodularis is one of those really exciting ones- a condition were individuals are incredibly itchy. There's huge quality of life concerns, people pick and scratch and there's huge nodules on their skin, oftentimes, without really great treatments. It looks like dupilumab is actually going to be a really good choice to help get that itch under control, and cause those lesions to retreat.

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