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IMMUNOLOGY

FDA Approves Glenmark Fluticasone Propionate Nasal Spray

by Team SunilMadhavs World August 24, 2026

FDA Approves Glenmark’s Fluticasone Propionate Nasal Spray

The U.S. Food and Drug Administration (FDA) has granted approval for fluticasone propionate nasal spray USP (0.05 mg per spray) developed by Glenmark Pharmaceuticals, according to a corporate press release. The product is positioned as a generic alternative designed to match established therapeutic options for allergic rhinitis symptoms.

Glenmark notes that its newly approved nasal spray is both bioequivalent and therapeutically equivalent to Flonase (Haleon). The formulation is indicated for the management of key allergy symptoms—including nasal congestion, runny nose, sneezing, itchy nose, and itchy and watery eyes—in adults and pediatric patients aged 4 years and older.

Clinical Impact and Access Strategy

Addressing the strategic significance of the approval, Marc Kikuchi, MBA, president and business head of North America at Glenmark Pharmaceuticals, stated:

“This will increase access to an already proven treatment option by ensuring timely supply across the market.”

Highlighting the company’s commitment to patient care and portfolio expansion, Kikuchi further remarked:

“It will also strengthen patient choice, help address a significant healthcare need and reinforce Glenmark’s focus on providing affordable respiratory products to customers in the country.”

Product Profile and Regulatory Overview

Product Attribute	Details
Active Ingredient	Fluticasone Propionate Nasal Spray USP
Dosage Strength	0.05 mg per spray
Manufacturer	Glenmark Pharmaceuticals
Brand Equivalence	Flonase (Haleon)
Approved Indications	Nasal congestion, runny nose, sneezing, itchy nose, itchy/watery eyes
Target Population	Adults and children aged 4 years and older

Zero-CLS Interactive Widget Code (WordPress / Soledad Theme)

To embed an interactive product profile explorer widget on a Soledad-themed WordPress site without triggering Cumulative Layout Shift (CLS), use the production-ready HTML, CSS, and JavaScript snippet below. It utilizes explicit structural bounding and a fixed viewport minimum height to eliminate layout jumps.

HTML

<!-- Zero-CLS Fluticasone Nasal Spray Explorer Widget -->
<div class="flut-widget-wrapper">
  <div class="flut-header">
    <h3>Glenmark Fluticasone Nasal Spray Overview</h3>
    <p>Select a category to review product specifications and regulatory details.</p>
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    <button class="flut-btn" onclick="switchFlutTab('equivalence')">Therapeutic Equivalence</button>
    <button class="flut-btn" onclick="switchFlutTab('impact')">Market Access</button>
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      <h4>Approved Indications & Target Age</h4>
      <p>Indicated for nasal congestion, runny nose, sneezing, itchy nose, and itchy/watery eyes in adults and children aged 4 years and older.</p>
    </div>
    <div id="flut-pane-equivalence" class="flut-content-pane">
      <h4>Bioequivalence & Dosing</h4>
      <p>Formulated at 0.05 mg per spray, confirmed as bioequivalent and therapeutically equivalent to Flonase (Haleon).</p>
    </div>
    <div id="flut-pane-impact" class="flut-content-pane">
      <h4>Healthcare Impact</h4>
      <p>Aims to strengthen patient choice, ensure reliable supply across the market, and expand access to affordable respiratory treatments.</p>
    </div>
  </div>
</div>

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.flut-header h3 {
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}
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<script>
function switchFlutTab(paneId) {
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  document.getElementById('flut-pane-' + paneId).classList.add('active');
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Zero-CLS Regulatory Summary HTML Code

The standalone summary card below highlights core metrics regarding the FDA approval. It is built using rigid CSS box-sizing constraints to guarantee zero layout shifting upon page rendering.

HTML

<div class="regulatory-summary-card-flut">
  <div class="rsc-badge-flut">FDA Approval Summary</div>
  <h4 class="rsc-title-flut">Glenmark Fluticasone Propionate Nasal Spray</h4>
  <p class="rsc-desc-flut"><strong>Core Impact:</strong> FDA approval of a bioequivalent alternative to Flonase, expanding affordable access to allergy management for adults and children aged 4+.</p>
  <div class="rsc-metrics-grid-flut">
    <div class="rsc-metric-box-flut">
      <span class="rsc-val-flut">0.05 mg</span>
      <span class="rsc-label-flut">Metered Dosage per Spray</span>
    </div>
    <div class="rsc-metric-box-flut">
      <span class="rsc-val-flut">Ages 4+</span>
      <span class="rsc-label-flut">Pediatric & Adult Indication</span>
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    <div class="rsc-metric-box-flut">
      <span class="rsc-val-flut">Flonase</span>
      <span class="rsc-label-flut">Therapeutic Equivalent Brand</span>
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  </div>
</div>

<style>
.regulatory-summary-card-flut {
  width: 100%;
  max-width: 800px;
  background: #ffffff;
  border-left: 4px solid #004080;
  border-top: 1px solid #dcdfe6;
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August 24, 2026 0 comments

“I am very excited about the next year or two where we are going to see numerous readouts, and hopefully, many of the programs can achieve successful primary endpoints so we can have them available for our patients so we can optimize long-term vision for our patients with neovascular AMD.”

Arshad M. Khanani, MD, MA, FASRS (Sierra Eye Associates)

New technologies advance wet AMD treatment space

by Team SunilMadhavs World November 28, 2025

written by Team SunilMadhavs World

At the American Academy of Ophthalmology meeting in Orlando, Arshad M. Khanani, MD, MA, FASRS (Sierra Eye Associates), highlighted significant advancements in the therapeutic pipeline for neovascular AMD. His presentation focused on two primary classes of emerging treatments: Tyrosine Kinase Inhibitors (TKIs) and gene therapies.

1. Tyrosine Kinase Inhibitors (TKIs)

Dr. Khanani detailed current clinical trials involving sustained-delivery TKI formulations designed to extend treatment intervals:

– OTX-TKI (axitinib implant): Developed by Ocular Therapeutix, this treatment is currently being evaluated in the SOL-1 and SOL-R clinical trials.

– Vorolanib: Developed by EyePoint Pharmaceuticals, this formulation is designed for a dosing schedule of once every six months. It is currently being studied in the LUCIA and LUGANO trials.

2. Gene Therapy Programs

The presentation also covered three major gene therapy candidates aimed at providing long-term solutions for wet AMD, distinguished by their delivery methods:

– Subretinal Delivery:

– ABBV-RGX-314: A collaboration between AbbVie and Regenxbio.

– Intravitreal Delivery:

– 4D-150: Developed by 4D Molecular Therapeutics.

– ADVM-022: Developed by Adverum Biotechnologies.

Expert Perspective

Khanani expressed strong optimism about the near future of AMD treatment, stating:

“I am very excited about the next year or two where we are going to see numerous readouts, and I’mhopefully, many of the programs can achieve successful primary endpoints so we can have them available for our patients so we can optimize long-term vision for our patients with neovascular AMD.”

This underscores his belief that upcoming trial results could pave the way for new therapeutic options that improve long-term visual outcomes for patients.

Disclosures: Dr. Khanani reported no relevant financial disclosures regarding this presentation.

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November 28, 2025 0 comments

DERMATOLOGY IMMUNOLOGY RHEUMATOLOGY

Enpatoran delivers robust skin lupus efficacy across CLE and SLE, achieving high CLASI responses and early IFN suppression in WILLOW trial

by Chnfo@suni0 November 27, 2025

written by Chnfo@suni0

Overview of Findings

Data presented at ACR Convergence 2025 in Chicago indicates that Enpatoran, a first-in-class oral small molecule Toll-like receptor 7/8 inhibitor, significantly outperforms placebo in treating mucocutaneous symptoms. The data supports its efficacy for patients suffering from both cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE).

According to lead researcher Eric F. Morand, MBBS, PhD, FRACP, of Monash University, the study was unique in its scope. He stated:

“Cutaneous disease is a feature of both cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus… This basket study offered for the first time an analysis of a medicine in the treatment of cutaneous lupus in both diagnostic categories.”

Study Design: The WILLOW Trial

The findings were derived from a post-hoc analysis of the WILLOW study, a Phase 2, randomized, double-blind, placebo-controlled trial. This “basket study” was designed to evaluate the impact of Enpatoran on skin disease severity using the Cutaneous Lupus Disease Area and Severity Index-Activity (CLASI-A).

The analysis focused on 262 patients from two specific cohorts:

Cohort A: Patients with SLE and CLE.
Cohort B: Patients with moderate-to-severe active SLE.
Baseline: All included patients had a CLASI-A score of 8 or higher at the start of the trial.

Key Efficacy Data

The study measured response rates using CLASI-50 (a 50% improvement) and CLASI-70 (a 70% improvement) benchmarks. Enpatoran demonstrated higher response rates compared to placebo at both 16 and 24 weeks.

Response Rates:

Metric	Timepoint	Enpatoran Group	Placebo Group
CLASI-50	Week 16	71.2%	37.3%
CLASI-50	Week 24	78.8%	37.3%
CLASI-70	Week 16	46.3%	14.9%
CLASI-70	Week 24	57.1%	25.4%

Commenting on these statistics, Morand noted:

“Very significant efficacy signals were seen across the pooled CLE and SLE patients, with high rates of achievement of CLASI-50 and CLASI-70.”

Remission and Biological Markers

The study also evaluated “treat-to-target” goals, specifically looking for remission or low disease activity.

Remission: A higher proportion of patients in the 50 mg and 100 mg Enpatoran groups achieved a Cutaneous Lupus Activity Investigator’s Global Assessment (CLA-IGA) score of 0 or 1 compared to placebo (nominal P < .0025).
Low Disease Activity (Week 24):
- Score 0–1: 30.2% of Enpatoran patients vs. 16.4% of placebo patients.
- Score 0–3: 56.3% of Enpatoran patients vs. 26.9% of placebo patients.

Regarding these specific endpoints, Morand highlighted:

“Even more interesting, draft definitions of remission were attained at higher rates in enpatoran-treated patients, the first time treat-to-target goals have been evaluated in skin lupus.”

Biologically, the drug also showed rapid action at the genetic level. Morand observed:

“Importantly, both patient groups also showed striking suppression of IFN gene signatures within 2 weeks of commencing treatment.”

Clinical Significance

The results offer a promising outlook for patients dealing with the mucocutaneous manifestations of lupus, a condition that currently lacks specific approved therapies.

Morand concluded:

“The results demonstrate that enpatoran is efficacious in mucocutaneous manifestations of lupus regardless of the underlying diagnosis of CLE or SLE. This is the one of the first positive efficacy findings of a potential treatment for this manifestation of lupus, for which there are no approved therapies, and the first in both CLE and SLE patients.”

Disclosures: Eric F. Morand reports extensive consulting, research support, and advisory roles with major pharmaceutical companies, including AbbVie, AstraZeneca, Bristol Myers Squibb, Eli Lilly, EMD Serono (Merck KGaA), and GlaxoSmithKline, among others.

November 27, 2025 0 comments

DERMATOLOGY IMMUNOLOGY TRIALS

Brepocitinib may emerge as the first targeted treatment option for dermatomyositis.

by Team SunilMadhavs World November 27, 2025

written by Team SunilMadhavs World

Background on Dermatomyositis

Dermatomyositis is a multiorgan inflammatory disease that causes severe muscle weakness and skin lesions, affecting about 40,000 adults in the U.S.. It can also lead to itchy rashes and impair organ function, especially in the lungs.

Anthony P. Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic, explained:

“Dermatomyositis is a relatively uncommon autoimmune disease. Traditionally, the medications that we have used are immunosuppressive medications; first and foremost, systemic corticosteroids, and then the more traditional steroid-sparing immunosuppressive medicines, such as methotrexate, azathioprine, mycophenolate, mofetil and tacrolimus. For several decades, we have also known that intravenous immunoglobulin, or IVIG, can be a very good treatment for patients with dermatomyositis, regardless of whether we are trying to treat the inflammation in the skin or the muscles.”

Study Design

Participants: 241 patients with definite or probable dermatomyositis.
Groups: Brepocitinib 15 mg (n=81), brepocitinib 30 mg (n=81), placebo (n=79).
Demographics: Mean age 50; over 70% women; over 70% on background corticosteroids.
Steroid tapering: Between weeks 12–36, corticosteroids reduced to <5 mg/day, with further tapering at investigator discretion.
Endpoints:
- Primary: Mean Total Improvement Score (TIS) at week 52 (30 mg vs placebo).
- Secondary: Disease activity across organ systems, quality of life, muscle strength, and skin outcomes.

Results

TIS scores: 46.5 (30 mg group) vs 31.2 (placebo), difference of 15.3 (P = .0006).
Response rates:
- Moderate response (TIS ≥40): 68% (30 mg) vs 44% (placebo), P = .004.
- Major response (TIS ≥60): 46% (30 mg) vs 26% (placebo), P = .0126.
Steroid independence: 42% of brepocitinib patients off corticosteroids at week 52 vs 23% placebo.
Skin remission: CDASI ≤5 achieved by 44% (30 mg) vs 21% placebo (P = .006).
Muscle & function: Significant improvements in DMOMS scores (P = .0014), proximal muscle strength, and disability (P = .0035).
Safety: Slight increase in serious infections, consistent with other TYK2/JAK1 inhibitors. Importantly,

“There were no deaths, cardiovascular or thromboembolic events during the study,” Fernandez noted.

Clinical Significance

Fernandez emphasized that these findings may represent a turning point in dermatomyositis care, introducing the first novel targeted therapy in decades:

“These data are exciting. There has not been a novel medicine approved for dermatomyositis in decades. An IVIG brand was officially approved by the FDA in 2021, but the reality is that this did not change our practice — we had already been using IVIG and had been able to get it covered by insurance for well over a decade prior to that FDA approval. These new data suggest that brepocitinib could be a novel medicine that, if approved by the FDA, really would change the treatment algorithm.”

Priovant plans to submit a new drug application to the FDA in early 2026. Fernandez added:

“Dermatomyositis can be challenging to treat, and it is not uncommon for patients to be on multiple immunomodulatory medications at the same time to try to get either the skin disease or the muscle disease — or sometimes both — under adequate control. If this drug is approved, it could be an addition that helps us more readily get our patient’s disease under control.”

Source & Disclosures

Study: Vleugels RA, et al. Efficacy and safety of brepocitinib in patients with active dermatomyositis: Results from a randomized, double-blind, multicenter, placebo-controlled, phase III (VALOR) trial. Presented at the Rheumatologic Dermatology Society annual meeting, Oct. 25, 2025, Chicago.
Disclosures: Priovant sponsored the VALOR study. Fernandez has served as a research investigator for AstraZeneca, Boehringer Ingelheim, Insight, Pfizer, and Priovant, and received consultant/speaking fees from Amgen, Biogen, Bristol Myers Squibb, EMD Serono, Galderma, and Mallinckrodt.

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November 27, 2025 0 comments

IMMUNOLOGY

FDA Approves Glenmark Fluticasone Propionate Nasal Spray