UnitedHealth Group’s Optum Rx is monitoring three notable drug candidates that might be approved in the next few months, according to its winter 2026 report published Jan. 2.
Two of the medications Optum Rx is tracking are also on GoodRx’s list of 11 upcoming FDA approval decisions to watch in 2026 — Anaphylm for anaphylaxis and Sotyktu for psoriatic arthritis.
Here is a breakdown of the three FDA decisions Optum Rx is closely watching:
1. Anaphylm (dibutepinephrine) is under FDA review for the treatment of severe allergic reactions, including anaphylaxis. If approved, the sublingual films will be the first oral epinephrine product for allergic reactions.
The manufacturer of Anaphylm, Aquestive Therapeutics, said Jan. 9 the FDA has “identified deficiencies in the [New Drug Application] that preclude discussion of labeling and post-marketing commitments.”
The FDA has not made a final decision, and Aquestive Therapeutics said it is working with the agency to resolve the issues. Optum Rx’s report, which was published before Aquestive’s Jan. 9 announcement, said the FDA’s decision on Anaphylm is expected by Jan. 31.
Optum Rx estimated Anaphylm will cost approximately $710 per two-dose package.
2. Bristol Myers Squibb is seeking another indication for Sotyktu (deucravacitinib), an FDA-approved pill for adults with moderate to severe plaque psoriasis.
The potential new indication is the treatment of adults with active psoriatic arthritis, a chronic autoimmune condition that affects about 1 million U.S. adults. An FDA decision is expected by March 6.
The medication currently costs $83,000 per year, according to Optum Rx.
3. Novo Nordisk resubmitted an application for FDA approval of insulin icodec, a once-weekly basal (long-acting) insulin to improve glycemic control in patients with Type 2 diabetes.
In 2024, an FDA advisory committee reviewed a phase 3 study that compared Novo Nordisk’s experimental weekly insulin icodec, Awiqli, to the drugmaker’s daily insulin product, Tresiba. The study found no additional glycemic control or other benefits in Awiqli.
“Across its five pivotal trials, insulin icodec was either statistically superior or not inferior to comparator insulins,” Optum Rx said, adding that an FDA decision is expected in the first quarter of 2026.
If approved, insulin icodec will likely be priced similar to Tresiba, which has a wholesale acquisition cost of approximately $6,000 per year, according to Optum Rx.
