May 2023 decisions expected from the FDA

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 U.S. Food and Drug Administration (FDA).

Drug pipeline for May 2023:

5/8/2023: MydCombi™ (phenylephrine and tropicamide) Ophthalmic Solution
The United States Food and Drug Administration (FDA) is reviewing Eyenovia’s MydCombi, an ophthalmic solution as a fixed combination micro-dose formulation for pharmacologic mydriasis administered in the eye care practitioner’s office. MydCombi’s application is supported by data from two Phase 3 studies, MIST-1 and MIST-2 that evaluated the efficacy and safety of MydCombi. Findings from both studies demonstrated that approximately 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-instillation.¹ MydCombi is seeking approval via the 505(b)2 pathway using tropicamide as its reference product.

5/22/2023: fezolinetant
Astellas’ fezolinetant is being reviewed by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Fezolinetant is an oral nonhormonal treatment that works as a selective neurokinin 3 (NK3) receptor antagonist. It is seeking approval based on the SKYLIGHT 1 trial of fezolinetant 30 mg and 45mg administered once daily which met its primary endpoint of demonstrating a statistically significant reduction from baseline in the frequency and severity of moderate to severe VMS at weeks 4 and 12 compared to placebo. The Institute for Clinical and Economic Review (ICER) stated fezolinetant’s evidence is rated as promising but inconclusive to determine whether fezolinetant provides a net health benefit for patients over the long term; however, using point estimates from short-term clinical trials, analyses suggest this drug would achieve common thresholds for cost-effectiveness if priced between $2,000 – $2,500 per year for women who cannot or choose not to take menopausal hormone therapy.²  Similar products include Pfizer’s Prempro^® (estrogens/conjugated/medroxyprogesterone acetate), Novo Nordisk’s Activella^® (estradiol/norethindrone acetate) and Bayer HealthCare Pharmaceutical’s Angeliq^®(drospirenone/estradiol) as well as estrogen-only competitors.

5/23/2023: Brixadi^® (buprenorphine depot)
Brixadi by Braeburn Pharmaceuticals is being reviewed by the FDA for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. Brixadi is a long-acting weekly and monthly subcutaneous injection formulation for administration by a health care professional. Patients currently being treated with other buprenorphine-containing products can start treatment with either Brixadi weekly or Brixadi monthly. Brixadi met the primary endpoint of non-inferiority for responder rate compared to once daily sublingual buprenorphine/naloxone in its clinical trial. The trial included real-world patients; 26% tested positive for fentanyl prior to study randomization, 71% were using heroin at study initiation and 52% were using injectable opioids at study initiation.³ If approved, Brixadi will compete with the other long-acting buprenorphine products, including: Probuphine^®, a six-month implant, and Sublocade^®, a monthly injection.

5/20/2023: Uzedy^® (risperidone extended-release injectable suspension)
Teva Pharmaceuticals and MedinCell’s Uzedy is seeking approval from the FDA as a subcutaneous injection once monthly or every two months for treatment of schizophrenia. Teva applied via the 505(b)(2) pathway using Janssen’s Risperdal^® (risperidone) as its reference product.⁴ Existing risperidone injectable products on the market include Indivior’s Perseris^® (risperidone) and Janssen’s Risperdal Consta^® (risperidone).

5/31/2023: Zynquista™ (sotagliflozin)
The FDA is reviewing Lexicon Pharmaceuticals’ Zynquista, a dual inhibitor of sodium-glucose co-transporter (SGLT) types 1 and 2. Zynquista is under review for the following indications:

• Reduce the risk of cardiovascular events in adults with heart failure, including those with acute or worsening heart failure.
• Reduce the risk of cardiovascular events in adults with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors, including a history of heart failure.

Zynquista is seeking approval based on the Phase 3 SOLOIST-WHF study which evaluated the cardiovascular efficacy of Zynquista versus placebo when added to standard of care. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with Zynquista compared with placebo. The rate of primary end point events was lower in the Zynquista group than in the placebo group (51.0 vs. 76.3). The rate of death from cardiovascular causes was 10.6 in the Zynquista group and 12.5 in the placebo group, the rate of death from any cause was 13.5 in the Zynquista group and 16.3 in the placebo group.⁵ Similar products include Boehringer Ingelheim/Eli Lilly’s Jardiance^® (empagliflozin) and AstraZeneca’s Farxiga^® (dapagliflozin) both of which have labeling for the reduction of risk of cardiovascular events in patients with T2D and cardiovascular disease.

5/2023: somatrogon
The FDA is reviewing Pfizer and Opko Pharmaceuticals’ somatrogon as a once-weekly treatment of pediatric patients with growth hormone deficiency (GHD). Somatrogon’s application is based on a Phase 3 trial evaluating the safety and efficacy of somatrogon administered once weekly which met its primary endpoint of non-inferiority compared to once daily Genotropin^® (somatropin) for injection. The primary endpoint of the trial was height velocity at 12 months. Somatrogon demonstrated the least square mean was higher in the somatrogon group (10.12 cm/year) than in the Genotropin group (9.78 cm/year); the treatment difference between somatrogon and Genotropin groups in height velocity (cm/year) was 0.33.⁶ Similar products include daily Novo Nordisk’s Norditropin^® (somatropin) and once daily Pfizer’s Genotropin^® (somatropin).

 Contact your Prime representative for more information or with any questions you have about drugs in the pipeline.

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References

1. https://icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-fezolinetant-for-vasomotor-symptoms-associated-with-menopause/

2. https://eyenovia.com/pipeline/mydriasis/
3. https://www.prnewswire.com/news-releases/fda-accepts-braeburns-new-drug-application-resubmission-for-brixadi-buprenorphine-extended-release-subcutaneous-injection-for-moderate-to-severe-opioid-use-disorder-301698779.html
4. https://www.fiercepharma.com/pharma/take-2-teva-refiles-approval-long-acting-schizophrenia-drug-months-after-fda-rejection
5. https://www.drugs.com/nda/zynquista_220727.html

https://www.opko.com/what-we-do/our-research/somatrogon