Overview of the Most Significant Drugs in Specialty Pharmacy FDA Pipeline in 2022

Pharmacy Times interviewed Ray Tancredi, divisional vice president of Specialty Pharmacy, Development & Brand Rx/Vaccine Purchasing at Walgreens, on his presentation at the Asembia Summit 2022 on the specialty pharmaceutical pipeline, and specifically what approvals pharmacists should look for on the horizon.

Question: What are some of the more significant drugs for specialty pharmacy in the FDA pipeline this year?

Ray Tancredi: That's a great question. I think there are a number of drugs that we're going to see approved now and before the end of the year. So I think one that you'll see before April is over is surufatinib—it's for advanced neuroendocrine tumor, it's by [Hutchison China MediTech Limited] and you can see that very shortly.

Toripalimab is for head and neck tumors. It's got priority review, and it's by Coherus Biosciences, and it even has orphan status.

Another drug could be approved today, and I do have it in my presentation at Asembia, but it's called mavacamten by [Bristol Myers Squibb]. It's for hypertrophic cardiomyopathy, it's a first-in-class product, and it's been shown to reduce cardiac muscle contractility and left ventricle hypertrophy. It was granted breakthrough therapy actually in China, and now the [Prescription Drug User Fee Act (PDUFA)] is, I think, actually today. So it's for chronic progressive disease with excessive contraction of the cardiac muscle and reduced ability of the left ventricle to fill—can be hereditary, and also can develop at any age, but we often see it happen at the age of 40 [years] and above.

So in May [and] June, you may not see a number of products, but in July you’ll see a drug called Hepcludex that's for hepatitis C and D virus by Gilead. Also in July, you’ll see a product, spesolimab, it's for psoriasis and generalized pustular psoriasis. And it's a first-in-class, it's a drug for rare life-threatening neutrophilic skin diseases. It's distinct from plaque psoriasis, but it's characterized by episodes of widespread eruptions, painful pustules, and 54% of the people with general pustular psoriasis also get plaque psoriasis. Right now, there's no FDA approved therapies. It's a high unmet need, and these patients have a lot of visits to the ER.

So, spesolimab is a first-in-class interleukin receptor antagonist. It's going to be the first FDA approved treatment if it's approved, and it was granted all the FDA designations like Breakthrough Therapy, orphan drug, priority review, and its expected approval could be May or June, or even July.

In August, we're going to see a couple products. Olumiant for alopecia areata, by Lilly, [and] you're also going to see teplizumab, which is for diabetes type 2. I think the manufacturer is Provention Bio.

And then we see a drug that's already been approved for asthma, and it's called dupixent by Regeneron. Again, it's already approved for asthma and atopic dermatitis. But if there is an evolving market, right, this is going to be for eosinophilic esophagitis, which is a chronic inflammatory disease of the digestive system. There are large accumulations of eosinophils in the esophagus. Right now, there's no FDA approved medication. They do use proton pump inhibitors and topical corticosteroids, but mainly it's food avoidance, and even esophageal dilation. So, again, for Dupixent, even though it's approved, that new indication will be the first drug approved for eosinophilic esophagitis and it has again it has all the breakthrough designations like orphan drug, priority review, etc.

And then, as we move through August and into September, BMS has another product that's looking pretty good. It's called Deucravacitinib for psoriasis. So as you can see, specialty pharmacy is gearing up for a number of these launches. It's very exciting, these could make an impact in the marketplace. So I think they're the drugs, along with a number of others, that we're looking at over the next 4 to 6 months.