January 2023 decisions expected from the FDA

Your monthly synopsis of new drugs expected to hit the market

December 5, 2022
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 January 2023

The United States Food and Drug Administration (FDA) is reviewing MediWound’s NexoBrid to remove nonviable burn tissue (eschar) within four hours of application without harming viable tissue. NexoBrid is a topical health care professional administered biological product that enzymatically removes nonviable burn tissue in patients with deep partial and full-thickness thermal burns. DETECT, a Phase 3 clinical trial, demonstrated that NexoBrid in adult patients with thermal burns up to 30% of total body surface area successfully met its primary endpoint of complete eschar removal compared to gel vehicle.1 Additionally, NexoBrid met all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Similar products include escharotomy.

The FDA is reviewing Eisai/Biogen’s lecanemab for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD). Lecanemab is an anti-amyloid beta protofibril antibody. Lecanemab is applying through the accelerated approval pathway using the Phase 2b, placebo-controlled trial which was unable to meet its primary endpoint of demonstrating the 80% probability threshold. The Phase 3 confirmaory CLARITY AD trial demonstrated that lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, a treatment difference in score change of -0.45 on the 18-point CDR-SB score.2,3 Starting as early as six months, across all time points, the treatment showed statistically significant changes in CDR-SB from baseline compared to placebo. Full approval submission based on the CLARITY AD trial is expected first quarter of 2023. Similar products include Eisai’s Aduhelm® (aducanumab).

1/15/2023:ACER-001 (sodium phenylbutyrate)
Acer Therapeutics/Relief Therapeutics’ sodium phenylbutyrate is seeking approval as an oral immediate-release powder formulation of the nitrogen-binding agent for treatment of urea cycle disorders (UCDs). ACER-001 was designed to increase palatability by containing a taste-masking coating that lessens its bitter taste and odor. ACER-001 is applying for approval via the 505(b)(2) pathway using Ucyclyd’s Buphenyl® (sodium phenylbutyrate) as its reference product.4 Similar products include Sobi’s Ravicti® (glycerol phenylbutyrate) and Ucyclyd’s Buphenyl® (sodium phenylbutyrate).

1/2023:PT027 (albuterol and budesonide)
The FDA is reviewing Avillion/AstraZeneca’s PT027 (albuterol and budesonide) as a fixed-dose combination of the inhaled corticosteroid (ICS) and the short-acting beta2 agonist (SABA) for pressurized metered dose inhaler (pMDI) delivery for as-needed treatment or prevention of bronchoconstriction and for prevention of exacerbations in asthma patients aged four years and older. PT027 would be the first ICS/SABA combination product approved in the United States. PT027 is seeking approval based on results from Phase 3 clinical trial MANDALA, that demonstrated with albuterol rescue, PT027 at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% in adults and adolescents. Members of the Pulmonary-Allergy Drugs Advisory Committee panel voted 16-1 that the data support a favorable benefit-risk assessment for use in patients ≥18 years of age with asthma, 9-8 that data do not support a favorable benefit-risk assessment in asthma patients ≥12 to <18 years and 16-1 that data do not support a favorable benefit-risk assessment in asthma patients ≥4 to <12 years of age.5.6 Many of those voting no noted that they weren’t concerned about safety, but rather didn’t see enough evidence supporting the benefit. Similar products include individual generic albuterol and budesonide.

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

While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner.


  1. https://www.empr.com/home/news/drugs-in-the-pipeline/fda-to-review-resubmitted-application-for-severe-burn-therapy-nexobrid/
  2. https://www.forbes.com/sites/joshuacohen/2022/11/14/gantenerumabs-phase-3-flop-means-lecanemab-emerges-as-favorite-in-antibody-class-targeting-amyloid-plaque-in-alzheimers-patients/?sh=5e2983f7277d
  3. https://www.pharmacytimes.com/view/lecanemab-shows-highly-statistically-significant-reduction-of-clinical-decline-in-early-alzheimer-disease
  4. https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/
  5. https://www.astrazeneca.com/media-centre/press-releases/2022/pt027-significantly-reduced-the-risk-of-a-severe-exacerbation-compared-to-albuterol-in-patients-with-asthma.html
  6. https://endpts.com/fda-adcomm-offers-thumbs-up-on-astrazenecas-2-in-1-asthma-inhaler-but-only-for-adults/

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