First once-weekly insulin for type 2 diabetes

Competitive environment

The primary treatment option for severe allergic reactions is injectable epinephrine (e.g., EpiPen^®, Auvi-Q^®), with generic versions of EpiPen accounting for approximately 90% of Optum Rx’s epinephrine prescriptions. If approved, dibutepinephrine would be the first non-device based, orally administered treatment for allergic reactions. Dibutepinephrine can be easily carried (it is approximately the size of a postage stamp) and is needle-free. These are both important aspects since patients at risk for severe allergic reactions often need to have a rescue medication on-hand when they are traveling.

In addition to injectable products, dibutepinephrine will also be competing with an intranasal epinephrine product, neffy. Like dibutepinephrine, neffy can be used in patients who are afraid of needles and is also relatively easy to transport. However, because neffy is administered through the nose, epinephrine absorption could be affected by disorders of the nose and sinuses (e.g., sinusitis, nasal polyps). Less than 3% of Optum Rx epinephrine prescriptions are for neffy.

For reference, the estimated wholesale acquisition cost for neffy, the last novel epinephrine-based non-injectable therapy, is approximately $710 per package (containing two doses). By comparison, the average ingredient cost per Rx for generic EpiPen is approximately $250.

Competitive environment

Many treatment options for psoriatic arthritis are available today, and include therapies that work in a variety of ways. These include nonsteroidal anti-inflammatory drugs (NSAIDs), conventional Disease-Modifying Antirheumatic Drugs (DMARDs) (e.g., sulfasalazine, methotrexate), injectable biologic DMARDs, and other oral DMARDs. These other oral DMARDs include Otezla (apremilast), and JAK (Janus kinase) inhibitors such as Rinvoq (upadacitinib) and Xeljanz (tofacitinib).

Sotyktu is a selective tyrosine kinase 2 (TYK2) inhibitor, a first-in-class treatment. While TYK2 inhibitors can be considered a subset of JAK inhibitors, they are highly selective for the TYK2 enzyme alone. This selectivity allows Sotyktu to be effective while improving safety. Most notably, Sotyktu does not have the boxed warnings seen with traditional JAK inhibitors, including serious infections, mortality, malignancy, major adverse cardiovascular events (e.g., death, non-fatal heart attack) and thrombosis (i.e., blood clots inside blood vessels).

Comparing effectiveness indirectly, Sotyktu had higher response rates compared to Otezla but lower than Xeljanz and Rinvoq. However, it is difficult to compare results across multiple trials due to differences in study populations.

In addition to competing with branded biologic and non-biologic DMARDs, several biosimilars are available for psoriatic arthritis, including biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab).

The oral treatment landscape is also expected to grow with J&J’s new treatment, icotrokinra. J&J has filed for FDA approval for icotrokinra to treat plaque psoriasis with expected approval in 2026. The response rates for icotrokinra for plaque psoriasis appear to be numerically better than other oral drugs, including Sotyktu. Icotrokinra is also being developed for psoriatic arthritis, but data is not yet available for this indication.

The estimated wholesale acquisition cost for Sotyktu based on its current availability for plaque psoriasis is approximately $83,0000 per year. In comparison, the estimated wholesale acquisition cost for Rinvoq is approximately $81,000.

Competitive environment

If approved, insulin icodec would be the first basal (or long-acting) insulin administered once weekly. The current basal insulins generally require once daily dosing. The primary differentiator for insulin icodec would be reducing the injection burden to once per week, without compromising glycemic control. Across its five pivotal trials, insulin icodec was either statistically superior or not inferior to comparator insulins.

A potential limitation with insulin icodec use is the risk of low blood sugar. In addition, current basal insulins are well-established, and their once-daily administration provides dosing flexibility that allows for easier dose adjustments.

Separately, Eli Lilly has an investigational once weekly insulin product (insulin efsitora alfa) which could be approved as early as the second half of 2026. Insulin efsitora alfa would represent direct competition to insulin icodec in patients who may benefit from once weekly insulin injections.

Insulin icodec is likely to be priced similar to Tresiba (insulin degludec), Novo Nordisk’s last novel basal insulin, which has a wholesale acquisition cost of approximately $6,000 per year. In comparison, once daily Lantus has a wholesale acquisition cost of approximately $1,000 per year.