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The Specialty Drug Pipeline Includes Two Treatments for Ulcerative Colitis


Eli Lilly’s mirikizumab and Pfizer’s etrasimod are expected to be approved by the FDA this year.

Two agents for treatment of ulcerative colitis were mentioned by Jeffrey Casberg, M.S., and Leslie Fish, Pharm.D., in their review of the specialty drug pipeline at the Academy of Managed Care Pharmacy (ACMP) annual meeting in San Antonio last month

Eli Lilly’s mirikizumab is a potential first-in-class antibody. Pfizer’s etrasimod is an oral once-daily treatment. Both are expected to be approved later this year.

In their presentation, Casberg and Fish, vice presidents of clinical pharmacy at IPD Analytics, highlighted over two dozen up-and-coming or recently approved specialty drugs for 2023. Definitions of specialty drugs vary from payer or payer. ACMP defines a specialty drug as one requiring considerable clinical monitoring for adverse effects and therapeutic outcomes or specialized training to handle or administer the drug. Specialty drugs typically have high price tags and target rare diseases. Although recent approvals have included also drugs for conditions affecting larger populations, such as Alzheimer’s disease, diabetes, atopic dermatitis and psoriasis.

Casberg and Fish said they expect mirikizumab to be priced so its annual cost will total between $80,000 and $150,000, using the wholesale acquistion cost (WAC T) price. They project etrasimod to be priced so the annual cost comes out to be between $75,000 to $100,000.

Mirikizumab is an interleukin (IL)-23 inhibitor monoclonal antibody for the potential treatment of moderate to severe ulcerative colitis. In the phase 3 LUCENT study, about one-half of participants taking mirikizumab achieved and maintained clinical remission at one year versus one-fourth of those in the placebo group.

Dosing for mirikizumab will be 300 mg by intravenous infusion every 4 weeks for 3 months, followed by 200 mg subcutaneous injections every 4 weeks.

Other IL-23 inhibitors in late-stage trials for ulcerative colitis include Tremfya (guselkumab) from Janssen Pharmaceuticals and Skyrizi (risankizumab) from AbbVie. The three agents are vying for FDA approval as the first IL-23 inhibitor for ulcerative colitis. Eli Lilly filed a biologics license application and is expecting an FDA decision soon.

Pfizer recently announced positive top-line results for the phase 3 ELEVATE 12 study of etrasimod in ulcerative colitis patients who did not respond to or did not tolerate at least one conventional, biologic, or Janus kinase inhibitor treatment. Etrasimod is a next generation selective sphingosine 1-phosphate (S1P) receptor modulator. The drug candidate will be taken orally as a once daily dose. The company filed a new drug application in late 2022 and is anticipating a FDA decision by the second half of 2023. If approved, etrasimod will compete with Zeposia (ozanimod) from Bristol Myers Squibb as the second oral S1P receptor modulator to treat ulcerative colitis.

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