July 2024 decisions expected from the FDA

Your monthly synopsis of new drugs expected to hit the market

June 14, 2024

Your monthly synopsis of new drugs expected to hit the market

FDA DECISIONS EXPECTED

At Prime Therapeutics (Prime), we’ve positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep a keen eye on drugs likely to be approved by the United States (U.S.) Food and Drug Administration (FDA).

Drug pipeline for July 2024

July 2024: deuruxolitinib

Sun Pharmaceuticals is seeking FDA approval for deuruxolitinib, an oral Janus kinase 1 and 2 (JAK1, JAK2) inhibitor, for the treatment of adults with moderate to severe alopecia areata. The FDA granted the product Breakthrough Therapy and Fast Track designations for this indication. Deuruxolitinib was evaluated in the THRIVE-AA1 double-blind clinical trial in adults with ≥ 50% scalp hair loss. At 24 weeks, 29.6% and 41.5% of patients who received twice daily doses of 8 mg and 12 mg of deuruxolitinib, respectively, met the primary efficacy endpoint of severity of alopecia tool (SALT) score ≤ 20% compared to 0.8% of patients who received placebo.¹ The similarly designed THRIVE-AA2 trial showed comparable results (SALT ≤ 20% in 33% and 38% of patients given deuruxolitinib versus 1% given placebo; p<0.0001).² If approved, deuruxolitinib will be the third Janus kinase inhibitor available in the U.S. for alopecia areata, joining ritlecitinib  (LITFULO®) and baricitinib (Olumiant®).

Jul-Sep 2024: insulin icodec (Awiqli)

Novo Nordisk is awaiting approval of insulin icodec for the treatment of adults with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). If approved, insulin icodec will be the first once-weekly insulin available in the U.S. In clinical trials, insulin icodec demonstrated noninferiority compared to once-daily insulin degludec based on hemoglobin A1C (HbA1c) lowering in patients with T1DM. Insulin icodec was also superior to once-daily insulin glargine 100 units/mL and insulin degludec for management of T2DM. In some studies, insulin icodec was associated with higher incidence of significant or severe hypoglycemia than its comparator insulin products. On May 24, 2024, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee determined the risk of hypoglycemia outweighs the benefits of fewer injections and potentially better adherence regarding the use of insulin icodec in adults with T1DM. The FDA has not posed a concern of insulin icodec’s efficacy or safety in patients with T2DM.

For more information, see the insulin icodec Deep Dive in the January 2024 edition of the Quarterly Pipeline Quarterly Drug Pipeline – Prime Therapeutics LLC

Jul-Dec 2024: lebrikizumab

Eli Lilly is awaiting an FDA decision for lebrikizumab for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis. This is the second review by the FDA after issuing a Complete Response Letter (CRL) in October 2023 due to site inspection concerns. Published data from the Advocate1 and Advocate2 trials revealed at one year of treatment lebrikizumab led to clear or almost clear skin in upwards of 65% of patients and a 75% improvement in upwards of 75% of patients who received the drug. Lebrikizumab received Fast Track designation from the FDA. If approved, it will be the second biologic for atopic dermatitis that primarily targets interleukin-13, following tralokinumab’s (Adbry) approval in December 2021 indicated for use in adults only. Lebrikizumab will most likely compete with Adbry and Dupixent® (dupilumab) in this patient population.

07/15/2024: naloxone (OX124)

The FDA is reviewing OX124 under their 505(b)(2) pathway as an intranasal rescue medication for opioid overdose. OX124, by Orexo, is a high dose naloxone formulation with potential for reversing overdose from synthetic opioids, such as fentanyl. If approved, it will be the first intranasal naloxone formulation using a powder-based technology that provides increased stability, with a long shelf-life and resistance to freezing in low temperatures. High-dose naloxone nasal sprays are currently available in the U.S. with a prescription and include Kloxxado (8 mg/dose) and Rezenopy (10 mg/dose).

07/27/2024: crovalimab

Crovalimab, a complement inhibitor C5 recycling monoclonal antibody, was submitted to the FDA for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The open-label COMMADORE 2 trial enrolled C5 inhibitor-naïve adults with PNH.³ Interim data demonstrated a similar proportion of patients achieved hemolysis control during weeks 5 to 25 with subcutaneous (SC) crovalimab administered every 4 weeks compared to intravenous (IV) eculizumab given every 2 weeks (79.3% versus 79%, respectively). The study also reported similar rates of transfusion avoidance in both groups (65.7% versus 68.1%, respectively). In addition, interim data from the COMMADORE 1 trial revealed that crovalimab maintained disease control in patients who switched from an FDA-approved complement inhibitor. Crovalimab received Breakthrough Therapy and Orphan Drug designations from the FDA. If approved, crovalimab may provide a self-administered option with once monthly dosing. It will compete with the complement inhibitors IV eculizumab (Soliris®) and IV/SC ravulizumab-cwvz (Ultomiris®) for treating PNH.

07/27/2024: galantamine benzoate (ALPHA-1062)

The FDA is reviewing ALPHA-1062 under the 505(b)(2) pathway for the mild-to-moderate Alzheimer’s disease. According to Alpha Cognition, ALPHA-1062 is an acetylcholinesterase inhibitor designed to have minimal gastrointestinal side effects. The sublingual formulation, appropriate for patients unable to swallow tablets, demonstrated active drug release in under 30 seconds with 90% bioavailability.4 In a phase 3 trial, ALPHA-1062 demonstrated bioequivalence to galantamine hydrobromide extended-release.5

07/31/2024: dasatinib (Dasynoc®)

Dasynoc, a tyrosine kinase inhibitor by Xspray, is under 505(b)(2) review by the FDA for the treatment of chronic myelogenous leukemia. This is the third review for the Orphan Drug after it received CRLs from the FDA in July 2023, requesting information to mitigate dosing errors, as well as in September 2022. Dasynoc is an oral immediate-release and amorphous solid dispersion (ASD) formulation of dasatinib and is bioequivalent to the original crystalline dasatinib (Sprycel®) at 30% lower dosages.6 Dasynoc is designed to lessen gastric pH dependency, therefore, minimizing drug-drug interactions, including proton-pump inhibitors for which concomitant use is not recommended with Sprycel. Dasynoc is not expected to be interchangeable with Sprycel or its generics.

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