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FDA Manufacturing Issues Delay Unicycive's Kidney Disease Drug Approval Process

Drug Approval
  • The FDA has identified manufacturing deficiencies at a third-party vendor for Unicycive Therapeutics' oxylanthanum carbonate, an investigational oral phosphate binder for kidney disease patients on dialysis.
  • The manufacturing issues have precluded FDA label discussions with the company, though a final decision is still expected by the June 28 PDUFA action date.
  • Oxylanthanum carbonate uses proprietary nanoparticle technology to deliver high phosphate binding potency while reducing pill burden for patients with hyperphosphatemia.
  • Unicycive's stock fell 27% in premarket trading following the announcement, as the company works with partners to resolve the FDA's cGMP compliance concerns.

AbbVie's Skyrizi and Rinvoq Drive Recovery as Humira Sales Plummet 50% Following Patent Loss

Drug Approval
  • AbbVie expects robust revenue growth in 2025, just two years after losing U.S. exclusivity for Humira in January 2023, with the flagship drug's sales declining nearly 50% to $1.12 billion in Q1 2025.
  • The company's ex-Humira platform grew over 21% year-over-year in Q1 2025, driven by newer immunology drugs Skyrizi and Rinvoq, which showed strong performance across inflammatory bowel disease indications.
  • AbbVie raised its guidance by $900 million and now expects $24.7 billion in combined sales from Skyrizi and Rinvoq this year, with potential for five new Rinvoq indications.
  • The immunology market remains highly competitive with Johnson & Johnson's Stelara and Tremfya, and Eli Lilly's recently approved Omvoh for ulcerative colitis and Crohn's disease.

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.

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

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

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

NCT04938830Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 11/30/2021

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 Placebo for the Treatment of Hypertension

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

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

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

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.

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