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FDA Approves XIFYRM Injectable Meloxicam for Moderate-to-Severe Pain Management

Drug Approval
  • The FDA has approved XIFYRM (meloxicam injection), a once-daily intravenous NSAID formulation for managing moderate-to-severe pain in adults.
  • The 30mg/mL injection is administered via IV bolus over 15 seconds and can be used alone or combined with non-NSAID analgesics.
  • XIFYRM addresses clinical needs for non-opioid alternatives in multimodal analgesia strategies, particularly amid ongoing efforts to reduce opioid dependence.
  • The drug is not recommended when rapid onset of analgesia is required due to its delayed onset profile.

FDA Approves Merck's ENFLONSIA for RSV Prevention in Infants with Single Weight-Independent Dose

Drug ApprovalMonoclonal Antibody
  • The U.S. FDA has approved Merck's ENFLONSIA (clesrovimab-cfor), a long-acting monoclonal antibody for preventing RSV lower respiratory tract disease in newborns and infants entering their first RSV season.
  • ENFLONSIA demonstrated a 60.5% reduction in RSV-associated medically attended lower respiratory infections and an 84.3% reduction in RSV-related hospitalizations compared to placebo in the pivotal CLEVER trial.
  • The therapy offers the first weight-independent dosing approach for RSV prevention, using a single 105 mg dose regardless of infant weight to provide protection through a typical 5-month RSV season.
  • Ordering is expected to begin in July 2025, with shipments delivered before the 2025-2026 RSV season, pending CDC Advisory Committee recommendations later this month.

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

NCT04938830CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 11/30/2021

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

NCT04767373CompletedPhase 2
Merck Sharp & Dohme LLC
Posted 4/7/2021

Citius Oncology Partners with Cardinal Health for LYMPHIR Distribution Ahead of Commercial Launch

Targeted TherapyDrug ApprovalOrphan Drug
  • Citius Oncology has entered into a distribution services agreement with Cardinal Health to support the upcoming U.S. commercial launch of LYMPHIR for cutaneous T-cell lymphoma treatment.
  • LYMPHIR is an FDA-approved targeted immunotherapy indicated for adults with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy.
  • The partnership leverages Cardinal Health's proven specialty pharmaceutical distribution capabilities to ensure efficient and reliable access to LYMPHIR for healthcare providers and patients.
  • Management estimates the initial market for LYMPHIR currently exceeds $400 million and is underserved by existing therapies.

Avanzanite Partners with Agios to Commercialize First-in-Class Pyruvate Kinase Activator Across Europe

Rare DiseaseDrug ApprovalOrphan Drug
  • Avanzanite Bioscience has secured exclusive European commercialization rights for PYRUKYND® (mitapivat), a first-in-class pyruvate kinase activator approved for treating adults with PK deficiency.
  • The partnership covers distribution across the European Economic Area, UK, and Switzerland, addressing an ultra-rare inherited condition that previously had no approved treatments.
  • Avanzanite plans to expand into 32 European countries over the next 12 months, having already tripled its Q1 2025 revenue year-over-year with two rare disease medicines currently on market.

Lipocine's Partner Files New Drug Submission for TLANDO in Canada, Targeting 700,000 Annual TRT Prescriptions

Drug Approval
  • Verity Pharma, Lipocine's licensing partner, has filed a New Drug Submission for TLANDO in Canada, marking a key regulatory milestone for the first FDA-approved oral testosterone replacement therapy that requires no dose titration.
  • The Canadian market represents a significant commercial opportunity with over 700,000 testosterone replacement therapy prescriptions written annually, approximately 50% covered by private insurance.
  • Limited promotional activities for existing TRT options in Canada could provide TLANDO with an opportunity to capture substantial market share in this large and growing therapeutic area.

FDA Approves First Triple-Combination Hypertension Drug WIDAPLIK for Initial Treatment

Drug Approval
  • The FDA has approved WIDAPLIK (telmisartan, amlodipine, and indapamide), marking the first and only triple-combination medication approved for initial hypertension treatment in adults.
  • Two Phase 3 trials demonstrated WIDAPLIK's superior blood pressure reduction compared to dual combinations and placebo, with good tolerability and safety profiles.
  • The single-pill combination addresses a critical unmet need, as nearly half of US adults have hypertension and only one in four achieve blood pressure control.
  • George Medicines plans to launch WIDAPLIK commercially in Q4 2025, potentially improving treatment adherence and outcomes for hypertension patients.

Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension

NCT04518293CompletedPhase 3
George Medicines PTY Limited
Posted 7/9/2021

Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension

NCT04518306CompletedPhase 3
George Medicines PTY Limited
Posted 6/14/2021

Glenmark Pharmaceuticals Receives DCGI Approval to Launch BRUKINSA for Five B-Cell Malignancies in India

Drug ApprovalOncology
  • Glenmark Pharmaceuticals has received DCGI approval to launch zanubrutinib (BRUKINSA) in India, marking the first BTK inhibitor approved for treating five distinct B-cell malignancies.
  • BRUKINSA is approved for chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma.
  • The drug is already approved in more than 70 countries globally and is supported by clinical evidence from pivotal trials including ALPINE, ASPEN, and SEQUOIA.
  • The launch represents a significant expansion of innovative oncology treatments for Indian patients through Glenmark's partnership with BeiGene (now BeOne Medicines).

Philippines FDA Expands VAT-Free Medicine List to Include New Cancer, Diabetes, and Cardiovascular Treatments

Drug Approval
  • The Philippines FDA has expanded its VAT-exempt medicine list to include additional treatments for cancer, diabetes, hypertension, and other conditions under President Marcos's directive to reduce medicine costs.
  • New cancer medications include Tegafur combination capsules and established treatments like Bortezomib, Docetaxel, Lenvatinib, Lenalidomide, and Paclitaxel.
  • Diabetes treatments now include Metformin-Teneligliptin combinations and Saxagliptin-Dapagliflozin tablets, while cardiovascular medicines feature new combination therapies.
  • The expansion covers 10 additional medications across multiple therapeutic areas including mental health treatments with Lamotrigine formulations.

Revolutionary Gene Therapy and BBB-Penetrating Treatments Transform Hunter Syndrome Treatment Landscape

Rare DiseaseDrug Approval
  • RGX-121, a one-time gene therapy using AAV vector technology, is expected to receive regulatory approval in the second half of 2025, potentially offering lifelong benefits from a single infusion for Hunter Syndrome patients.
  • Tividenofusp alfa and Verenafusp alfa represent breakthrough therapies designed to cross the blood-brain barrier, addressing both CNS and somatic symptoms that current treatments like Elaprase cannot reach.
  • The Hunter Syndrome treatment paradigm is shifting from weekly enzyme replacement therapy costing over $500,000 annually to potentially curative single-dose treatments targeting neurological decline.
  • IZCARGO, launched in Japan in 2021, currently stands as the only approved therapy addressing both somatic and CNS symptoms by crossing the blood-brain barrier, though availability remains limited to the Japanese market.

Safety and Efficacy of HMI-203 in ERT-Treated Adults With MPS II

NCT05238324WithdrawnPhase 1
Homology Medicines, Inc
Posted 9/8/2022

FDA Approves Moderna's Next-Generation COVID-19 Vaccine mRNA-1283 with Enhanced Efficacy

Drug Approval
  • The FDA has approved Moderna's new COVID-19 vaccine mRNA-1283 (mNEXSPIKE), marking the first authorization under updated federal guidelines prioritizing vaccination for adults 65 and older.
  • In a Phase 3 trial of over 11,000 participants, mRNA-1283 demonstrated 9.3% higher relative vaccine efficacy compared to Moderna's original vaccine, with 13.5% increased efficacy in adults 65 and older.
  • The vaccine showed a comparable safety profile with fewer local side effects and will be available for the 2025-2026 respiratory virus season in the U.S.
  • COVID-19 vaccination remains available for children 6 months and older through shared clinical decision-making, reflecting ongoing federal adjustments to immunization recommendations.

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