Ragwitek (ragweed allergy vaccine sublingual tablet) / ALK-Abello - LARVOL DELTA

Post-marketing safety evaluation and objective benefit-risk assessment of sublingual immunotherapy tablets in allergic rhinitis. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Reports including Oralair®, Grazax®/Grastek®, Ragwitek®, and Odactra® as suspected drugs were analyzed descriptively. SLIT tablets demonstrate a favorable safety profile with a positive benefit-risk balance. They represent an effective and generally safe option for allergic rhinitis when appropriate patient selection and clinical monitoring are ensured."

Benefit-risk assessment • Journal • P4 data • Allergic Rhinitis • Dermatology • Immunology • Inflammation • Pruritus • Pulmonary Disease

Safety Of Home-Based Reinitiation Of Sublingual Immunotherapy: A Multi-Allergen Retrospective Chart Review (AAAAI 2026) - "This study evaluates the safety of at-home SLIT reinitiation for grass (grastek), ragweed (ragwitek), and birch (itulatek) tablets. These findings add real-world support to CSACI’s COVID-19-era guidance on home SLIT reintroduction. However, larger and multi-center studies are needed to further evaluate safety and inform future guideline development."

Retrospective data • Review • Dermatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Pruritus

Non- interventional studies with the SQ grass, tree, ragweed, and house dust mite SLIT- tablets – a systematic literature review (EAACI 2023) - "Method PubMed, ClinicalTrials.gov, and EU Clinical Trials Register were screened for NISs with SQ grass, tree, ragweed, and HDM SLIT-tablets in June 2022 using the string (Product Surveillance, Postmarketing[MH] OR post-marketing OR post-authorization OR cohort or case-control OR observational OR non-interventional OR prospective OR real-world OR retrospective OR drug utilization OR longitudinal) AND (grazax OR itulazax OR ragwizax OR acarizax OR grastek OR itulatek OR ragwitek OR miticure OR odactra OR ALK[AD] OR ALK-abello[AD]) AND (2006/01/01 [PDAT] : 2022/06/15[PDAT]). Conclusion The totality of real-world clinical evidence from NISs with the SQ grass, ragweed, and HDM SLIT-tablets is substantial and further complements the efficacy and safety profile established in RCTs. NISs studying clinical efficacy and safety of the SQ tree SLIT-tablet is warranted."

Review • Allergic Rhinitis • Allergy • Immunology • Inflammation

Vestibular Versus Sublingual Route of AIT Tablets (clinicaltrials.gov) - P4 | N=172 | Completed | Sponsor: Clinique Spécialisée en Allergies de la Capitale | Active, not recruiting ➔ Completed | Trial completion date: Aug 2022 ➔ Apr 2022

Trial completion • Trial completion date • Allergy • Immunology

"Odactra grastek ragwitek" (,@what__the__hek)

Vestibular Versus Sublingual Route of AIT Tablets (clinicaltrials.gov) - P4 | N=200 | Active, not recruiting | Sponsor: Clinique Spécialisée en Allergies de la Capitale | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2022 ➔ Aug 2022 | Trial primary completion date: Jan 2022 ➔ Apr 2022

Enrollment closed • Trial completion date • Trial primary completion date • Allergy • Immunology

Desensitization and Cross-Desensitization During Oral Grass or Ragweed Pollen Immunotherapy (clinicaltrials.gov) - P3 | N=58 | Terminated | Sponsor: Virginia Commonwealth University | N=21 ➔ 58

Enrollment change • Immunology • CD63

Vestibular Versus Sublingual Route of AIT Tablets (clinicaltrials.gov) - P4; N=200; Recruiting; Sponsor: Clinique Spécialisée en Allergies de la Capitale

Clinical • New P4 trial • Allergy • Immunology

Desensitization and Cross-Desensitization During Oral Grass or Ragweed Pollen Immunotherapy (clinicaltrials.gov) - P3; N=21; Terminated; Sponsor: Virginia Commonwealth University; Phase classification: P=N/A ➔ P3; N=30 ➔ 21

Enrollment change • Phase classification • Immunology • CD63

"Nolte: Replicate trials of Ragwitek in adults showed consistent improvements of 24 to 28% compared to placebo in combined score (symptoms plus rescue med use)" (,@DrAnneEllis)

Clinical

"Nolte: Ragweed tablet (Ragwitek) now approved by Health Canada for pediatric use in children 5 y of age and up" (,@DrAnneEllis)

Canadian regulatory • Clinical • Pediatrics

Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008) (clinicaltrials.gov) - P3; N=1000; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Biosimilar • Inflammation • Ocular Inflammation

Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (MK-3641-006) (clinicaltrials.gov) - P4; N=100; Not yet recruiting; Sponsor: Merck Sharp & Dohme Corp.

New P4 trial • Biosimilar • Immunology

Ragweed allergy immunotherapy tablet MK-3641 (Ragwitek®) for the treatment of allergic rhinitis. (PubMed, Expert Rev Clin Immunol) - "Only one, non-serious systemic reaction was reported in 4 safety studies. MK-3641 is a safe and effective treatment for ragweed-pollen-induced AR when treatment is initiated ≥ 12 weeks prior to the onset of the ragweed pollen season."

Journal