Robust Pipeline of 50+ Therapies Reshaping Moderate to Severe Atopic Dermatitis Treatment Landscape
• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition.
• Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments.
• Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.
FDA Approves Sun Pharma's Next-Generation LED BLU-U Device for Actinic Keratosis Treatment
• The FDA has granted premarket approval for Sun Pharma's next-generation BLU-U Blue Light Photodynamic Therapy Illuminator, featuring LED panels instead of fluorescent tubes for treating actinic keratosis.
• The new LED BLU-U maintains the same safety and efficacy profile while offering a more compact design with a five-panel shape, improved LED arrangement, and enhanced functionality for better patient comfort.
• Approved under FDA's Real-Time Review Program, the device works in combination with LEVULAN KERASTICK topical solution to effectively target and clear actinic keratoses on the face, scalp, and upper extremities.
FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities to Level Global Oversight
• The FDA has announced plans to significantly expand unannounced inspections at foreign manufacturing facilities producing food, medicines, and medical products for U.S. consumers.
• Despite receiving advance notice of inspections, foreign facilities were found to have serious deficiencies more than twice as often as domestic sites, highlighting the need for stricter oversight.
• FDA Commissioner Dr. Martin Makary emphasized ending the "double standard" where foreign manufacturers received advance notice while U.S. companies faced rigorous unannounced inspections.
Sun Pharma and Moebius Medical's MM-II Shows Promising Results for Knee Osteoarthritis in Phase 2b Trial
• A single injection of MM-II, a novel non-opioid treatment developed by Sun Pharma and Moebius Medical, demonstrated clinically meaningful pain relief for knee osteoarthritis lasting up to 26 weeks in a Phase 2b trial involving 397 patients.
• MM-II's unique mechanism of action forms a lubricative layer over cartilage surfaces, reducing friction and slowing cartilage degeneration, as detailed in two peer-reviewed publications in Osteoarthritis and Cartilage journal.
• The treatment recently received Fast Track Designation from the US FDA and could offer a promising alternative to current treatments in the $2 billion global market for knee osteoarthritis pain relief.
Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate
• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests.
• The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods.
• The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.
U.S. Court Ruling Clears Path for Sun Pharma's Alopecia Drug Leqselvi Launch
• The U.S. Court of Appeals for the Federal Circuit has vacated a preliminary injunction against Sun Pharma, allowing the company to proceed with launching Leqselvi (deuruxolitinib) for alopecia areata in the American market.
• Sun Pharma acquired Leqselvi through its $576 million Concert Pharma acquisition in 2023, positioning it as a key product in its specialty portfolio that recently surpassed $1 billion in annual sales.
• The patent infringement litigation with Incyte Corporation continues, but Sun Pharma is no longer restricted from launching the drug, which analysts project could contribute $90 million to sales in FY26 and $125 million in FY27.
Robust Pipeline of 80+ Therapies Advancing in Psoriasis Treatment Landscape
• DelveInsight's 2025 Psoriasis Pipeline Report reveals over 80 companies developing 80+ pipeline therapies, highlighting significant R&D investment in this therapeutic area.
• Promising treatments in development include topical roflumilast (Arcutis Biotherapeutics) in Phase III trials and GSK2982772 (GlaxoSmithKline), a novel RIPK1 inhibitor in Phase I development.
• Alumis Inc. has initiated a long-term extension study for ESK-001 in moderate to severe plaque psoriasis patients, evaluating safety, efficacy, and durability of response over 24 weeks.
Fortress Biotech Reports Strong 2024 Results with Two FDA Approvals and Strategic Acquisition Deal
• Fortress Biotech secured FDA approvals for two key products in Q4 2024: Emrosi for inflammatory lesions of rosacea and UNLOXCYT for advanced cutaneous squamous cell carcinoma, with commercial launch of Emrosi already underway.
• Subsidiary Checkpoint Therapeutics is being acquired by Sun Pharma in a deal valued at $4.10 per share plus potential CVR of $0.70, expected to generate approximately $28 million for Fortress plus a 2.5% royalty on UNLOXCYT sales.
• FDA accepted New Drug Application for CUTX-101 for priority review with PDUFA date of September 30, 2025, potentially qualifying for a valuable Priority Review Voucher upon approval.
Sun Pharma to Acquire Checkpoint Therapeutics in $355 Million Deal for Novel Skin Cancer Treatment
• Sun Pharmaceutical Industries will acquire Checkpoint Therapeutics for $355 million upfront, with stockholders receiving $4.10 per share plus a contingent value right worth up to $0.70 per share based on European approval milestones.
• The acquisition adds UNLOXCYT (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma (cSCC), to Sun Pharma's global onco-dermatology portfolio.
• Sun Pharma plans to leverage its global presence to accelerate patient access to UNLOXCYT in the United States, Europe, and other markets worldwide, addressing a significant unmet need in the second most common skin cancer.
Indian Pharma Companies to Launch Generic Empagliflozin at 90% Lower Cost
• Several Indian pharmaceutical companies are preparing to launch generic versions of Empagliflozin following Boehringer Ingelheim's patent expiry on March 11, potentially transforming diabetes treatment accessibility.
• Mankind Pharma plans to offer the diabetes medication at approximately Rs 6 per tablet, a 90% reduction from the innovator's price of Rs 60, with most generic versions expected to cost between Rs 9-14 per tablet.
• The affordable generics will significantly reduce therapy costs for India's 10.1 crore diabetic patients, most of whom pay out-of-pocket, while still providing benefits for heart failure and chronic kidney disease management.
First Patients Receive Groundbreaking Autologous Stem Cell Treatment for Parkinson's Disease in Phase 1 Trial
• Mass General Brigham launches pioneering Phase 1 trial using patients' own reprogrammed stem cells to replace damaged dopamine neurons in Parkinson's disease, with three of six participants treated successfully.
• The innovative treatment converts patients' blood cells into induced pluripotent stem cells (iPSCs), which are then transformed into dopamine neurons, eliminating the need for immunosuppression.
• The FDA-approved trial, based on three decades of research at McLean Hospital, will monitor patients for 12 months to assess safety and potential improvements in Parkinson's symptoms.
Pfizer's Litfulo Becomes First NHS-Approved Treatment for Severe Alopecia Areata
• NICE has recommended Pfizer's Litfulo (ritlecitinib) as the first NHS-approved drug therapy for severe alopecia areata, affecting approximately 14,000 people in the UK.
• In the ALLEGRO trial, Litfulo demonstrated significant efficacy with 23% of treated patients achieving 80% hair coverage compared to 1.6% in the placebo group.
• The once-daily oral medication is approved for patients aged 12 and over, marking a breakthrough in treating this autoimmune disorder that impacts roughly 2% of the population lifetime.
UK MHRA Approves Winlevi®, First Novel Acne Treatment in 40 Years
• Winlevi® (clascoterone cream 1%), the first topical androgen receptor inhibitor for acne, receives MHRA approval for patients 12 years and older in the United Kingdom.
• Phase III studies demonstrated superior efficacy of Winlevi® over vehicle cream in reducing both inflammatory and non-inflammatory acne lesions, with a favorable safety profile.
• The approval represents a significant advancement in acne treatment, offering a new mechanism of action that targets sebum production without systemic anti-androgen effects.
FDA Approves Lilly's Omvoh (mirikizumab) for Crohn's Disease
• The FDA has approved Eli Lilly's Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease in adults, expanding its use for inflammatory bowel disease.
• The approval was based on the VIVID-1 trial, which showed significant clinical remission and endoscopic response rates compared to placebo after one year of treatment.
• Omvoh is the first biologic in over 15 years with Phase 3 two-year efficacy data at launch, demonstrating long-term disease control and visible healing of the intestinal lining.
• Lilly has submitted marketing applications globally, aiming to provide a new treatment option for Crohn's patients and is working with insurers to enable patient access.
Johnson & Johnson Seeks FDA Approval for Tremfya to Treat Pediatric Psoriasis and Arthritis
• Johnson & Johnson has submitted sBLAs to the FDA for Tremfya (guselkumab) to treat moderate-to-severe plaque psoriasis in children aged 6 and older.
• The submission also seeks approval for Tremfya to treat active juvenile psoriatic arthritis in children aged 5 and older.
• The sBLAs are based on data from the Phase 3 PROTOSTAR study and pharmacokinetic data from adult studies VOYAGE 1 and 2, and DISCOVER 1 and 2.
• Tremfya, an IL-23 inhibitor, is already approved for adults with plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
J&J's Oral IL-23 Inhibitor Icotrokinra Achieves Positive Phase 3 Results in Psoriasis
• Johnson & Johnson's icotrokinra met primary endpoints in the ICONIC-LEAD phase 3 trial, demonstrating significant skin clearance in psoriasis patients.
• After 16 weeks, 64.7% of patients achieved clear or almost clear skin (IGA 0/1), and 49.6% showed a 90% or greater improvement in PASI score.
• Icotrokinra's tolerability profile was consistent with previous phase 2 studies, with similar adverse event rates compared to placebo.
• J&J plans to submit icotrokinra for regulatory approval, positioning it as a potential oral alternative to injectable biologics for psoriasis.
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