The Biggest Drug Competition in 2021 (Hint: It Isn't COVID Vaccines)

In this video from Motley Fool Live, recorded on Jan. 4, Corinne Cardina, bureau chief of healthcare and cannabis, and Fool.com contributor Brian Orelli discuss the upcoming four-way competition for patients with eczema. Regeneron Pharmaceuticals (REGN -0.68%) and Sanofi (SNY 0.68%) have captured a large share of the moderate-to-severe patients with their injected drug Dupixent. But there's still plenty of market share available for drugs that can be delivered orally or topically.

Corinne Cardina: Any other big indications that you're going to watch this year beyond Biogen?

Brian Orelli: Yeah. We have a four-drug race, I think, in atopic dermatitis -- most people call that eczema. It affects 10% of adults and 20% of children worldwide. Many of those can be taken care of with topical generics. But there's still a pretty large market for moderate-to-severe patients.

Pfizer (PFE 0.19%) has abrocitinib, which is -- actually all four of these are JAK [Janus kinase] inhibitors. They're looking for an FDA [Food and Drug Administration] decision expected in April.

AbbVie (ABBV -0.38%) has Rinvoq. That's a brand name because it's already approved for rheumatoid arthritis. Also a JAK inhibitor. They submitted to the FDA and the EMA [European Medicines Agency] at the end of October. I haven't seen an acceptance from the FDA yet, which would start the date for when you would expect an FDA approval. But it should happen probably in October of next year, assuming they get a standard approval review.

Then Eli Lilly (LLY -0.12%) and Incyte (INCY -0.78%) have Olumiant. It's approved for rheumatoid arthritis. It's been approved for eczema in the EU, and then we should start to see the U.S. approval shortly -- application for the U.S. approval shortly -- if they haven't done that already.

Then Incyte has a cream that's a form of their same active ingredient as their JAK inhibitor, it's called Jakafi, which treats, I think a blood cancer [Editor's note: myelofibrosis]. They're planning on submitting a marketing application to the FDA. They were planning on doing it at the end of 2020, so it should happen pretty soon if they haven't done already. Then they have a priority review voucher which would give it an eight-month review period, so look for maybe [an] August, September time frame. The priority-review voucher will shave off four months off of a standard review.

Cardina: Sure. So can you remind us what a JAK inhibitor is, and why something that works for rheumatoid arthritis also works for eczema?

Orelli: Yeah. So rheumatoid arthritis and eczema are caused by inflammation, and JAK inhibitors inhibit the immune cells from attacking the patient's body; they're both autoimmune diseases. That's why Jakafi, which I said treats a blood cancer -- so that blood cancer is an immune cell, and so it's dampening the growth of the immune cell for the blood cancer.

Cardina: Excellent. Any thoughts on a potential winner in this market?

Orelli: Definitely the biggest loser is probably going to be Dupixent, which is from Regeneron and Sanofi. That drug has done really well. They had over $1 billion in global sales just in the third quarter alone, although some of that's for asthma and nasal polyps. It has to be injected, compared to the topical or oral JAK inhibitors. I think they'll be able to compete quite well.

Among the JAK inhibitors, I think it's hard to know for sure. They haven't been running any head-to-head clinical trials, so it's hard to know which one is going to win. I think Incyte might have an edge being a topical, because doctors may not want to inhibit the rest of the immune system fighting viruses. But if you're applying it to just your skin, you're more likely to have it act just locally, versus globally with an oral JAK inhibitor.