The world's first long-acting C5 inhibitor! Ultomiris 100mg/mL high concentration preparations are FDA approved, significantly reducing treatment time!

October 13, 2020 // -- Alexion is a biopharmaceutical company dedicated to the development of new drugs for rare diseases.
, the company announced that the U.S. Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvz) 100mg/mL preparation: (1) therapeutic thymoglobin Urine (PNH) adult patients; (2) treatment of atypical hemolytic uremic syndrome (aHUS) in adults and children (≥1 month) patients to inhibit complement-mediated thrombosis microvascular disease (TMA).
Ultomiris 100mg/mL preparation represents an advance in clinical treatment experience for patients with aHUS and PNH, as Ultomiris 100mg/mL preparations reduce average annual infusion time by approximately 60% compared to Ultomiris 10mg/mL preparations, while having a comparable safety and ability.
Ultomiris 100mg/mL preparation, most patients receive no more than 6 hours of treatment per year.
Ultomiris 100mg/mL preparation is also under review by EU and Japanese regulators.
recently, the European Medicines Agency's (EMA) Commission on Human Pharmaceutical Products (CHMP) issued a positive opinion recommending approval of the Ultomiris 100mg/mL preparation, which is expected to be approved in November.
Alexion plans to bring Ultomiris 100mg/mL preparations to market in a few days and develop a comprehensive training program.
Ultomiris 10mg/mL preparation will continue to be available until mid-2021.
, Alexion will withdraw its Ultomiris 10mg/mL preparation from the market after communicating with the FDA.
transition period is designed to provide seamless conversion without disrupting the patient's infusion program.
Ultomiris is the first and only long-acting C5 supplement inhibitor to receive regulatory approval, and based on strong efficacy and differentiation characteristics, pharmaceutical market research agency Evaluate Pharma had forecast sales of $3.43 billion in 2024.
, Alexion is continuing its Ultomiris innovation with the goal of improving the patient experience.
, after completing its ongoing Phase 3 clinical study and collecting 12 months of safety data, plans to submit regulatory filings for Ultomiris' combination of Ultomiris skin preparations and devices to treatment PNH and AHU in the third quarter of 2021, an innovative product that allows patients to self-administration at home and significantly reduces the time it takes to administration and reduces Ultomiris treatment to about 10 minutes.
PNH is a blood disease characterized by complement-mediated red blood cell destruction that can cause a wide range of debilitating symptoms and complications, including thrombosis that can occur throughout the body and lead to organ damage and premature death.
aHUS can cause progressive damage to vital organs (mainly the kidneys) by damaging blood vessel walls and blood clots.
affect both adults and children and are in critical condition, often requiring supportive care in intensive care, including dialysis.
in many cases, aHUS and PNH have poor prognosis, so timely and accurate diagnosis and appropriate treatment are key to improving patient prognosis.
() Origin: Alexion Receives FDA approval for New Advanced Development Of ULTOMIRIS? (ravulizumab-cwvz) with GreatLy Reduced Infusion Time.