공고 • May 04
Mallinckrodt Presents Data Evaluating Acthar Gel for the Treatment of Severe Keratitis at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting Mallinckrodt plc announced data from its Phase 4, multi-center, open-label study to assess the efficacy and safety of Acthar Gel (repository corticotropin injection) in adult patients with treatment-resistant, severe non-infectious keratitis, a disease which involves painful inflammation of the cornea.1 The full results were presented in a poster at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, and further data will be shared at the upcoming virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting. Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation. Please see Important Safety Information for Acthar Gel below. The primary efficacy endpoint of the study was the proportion of patients who improved by 12 points or more in the symptom bother module of the Impact of Dry Eye on Everyday Life (IDEEL) score at week 12. The IDEEL is a patient-reported outcome assessment with three modules "impact on daily life, treatment satisfaction and symptom bother "and six dimensions. After 12 weeks of treatment with Acthar Gel, 50.0% (n=17) of patients experienced improvements in their symptom bother score by at least 12 points, a clinically important change (95% CI 33.2, 66.8). 공고 • May 01
Mallinckrodt plc Presents Data Evaluating Inomax® (Nitric Oxide) Gas, for Inhalation in a Phase 4 Observational Registry in Neonates with Pulmonary Hypertension Mallinckrodt plc announced that data from its Phase 4 observational registry comparing the safety and effectiveness of INOmax® (nitric oxide) gas, for inhalation, in term and near-term (TNT) neonates to that in preterm (PT) neonates with pulmonary hypertension (PH) will be presented in a poster at The Pediatric Academic Societies (PAS) 2021 Virtual Meeting. The safety and efficacy of INOmax in premature neonates has not been evaluated by the U.S. Food and Drug Administration. INOmax has been on the market in the U.S. since 2000 and is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. The primary outcome measure of the registry was the number of PT neonates and TNT neonates with a significant response to INOmax, which was defined as at least a 25% improvement (decrease) from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOmax treatment. 공고 • Mar 05
Mallinckrodt Announces New England Journal of Medicine Publication of Results from its Phase 3 CONFIRM Study of Terlipressin in Patients with Hepatorenal Syndrome Type 1 (HRS-1) Mallinckrodt plc announced publication of results from its pivotal Phase 3 CONFIRM study to assess the efficacy and safety of its investigational agent terlipressin in adults with hepatorenal syndrome type 1 (HRS-1). HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in patients with cirrhosis,1 and has a median survival time of approximately two weeks and greater than 80% mortality within three months if left untreated. Terlipressin is an investigational product and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration (FDA) or Health Canada. As previously announced, the Phase 3 CONFIRM study met its primary endpoint of Verified HRS Reversal, which is defined as renal function improvement, avoidance of dialysis and short-term survival. The main objective of the CONFIRM study was to assess the efficacy and safety of terlipressin, together with albumin, versus placebo in adults in the U.S. and Canada with cirrhosis and HRS-1. The trial met three of the four pre-specified secondary endpoints of the study including HRS reversal, HRS reversal without renal replacement therapy (RRT) by Day 30 and HRS reversal in the systemic inflammatory response syndrome (SIRS) subgroup. In another pre-specified endpoint, avoidance of RRT, terlipressin treated subjects (n=199) showed a significantly lower incidence during the treatment period and a lower incidence at all follow-up assessments through Day 90 versus patients with placebo (n=101).4 This is clinically significant because RRT can increase complications in HRS-1 due to the underlying cirrhosis. The incidence of adverse events (AEs) of any severity were similar in both groups (88.0 percent of the terlipressin group and 88.9 percent of the placebo group). The most commonly reported AEs in the overall study population were abdominal pain, nausea, diarrhea, hepatic encephalopathy and dyspnea. Serious AEs (SAEs) were reported in 65.0 percent (n=130) of the terlipressin group and 60.6 percent (n=60) of the placebo group. The most commonly reported SAEs included hepatobiliary disorders, respiratory disorders and gastrointestinal disorders. 공고 • Feb 27
Silence Therapeutics plc & Mallinckrodt plc Initiate Work on 3Rd Target Silence Therapeutics plc announced the Company will receive a $2.0 million milestone payment following the initiation of work on a third target being explored under its ongoing RNAi research collaboration with Mallinckrodt plc for the treatment of complement pathway-mediated diseases. The collaboration is focused on the development and commercialization of RNAi therapeutics designed to inhibit or 'silence' the complement cascade, a group of proteins that are involved in the immune system and play a role in the development of inflammation. Using Silence's proprietary mRNAi GOLD (GalNAc Oligonucleotide Discovery) Platform, each target in the collaboration will be investigated before progressing into clinical development. 공고 • Feb 13
Mallinckrodt Provides Regulatory Update on StrataGraft® Mallinckrodt plc announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it is deferring action (pending a site inspection) on the Stratatech Biologics License Application (BLA) for StrataGraft®, an investigational allogeneic cellularized scaffold product in development for the treatment of adult patients with deep partial-thickness burns. This is due to COVID-19-related travel restrictions, which are delaying a required manufacturing site inspection. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), has provided funding and technical support for the continued development of StrataGraft under Project BioShield Contract. The FDA granted the BLA for StrataGraft priority review. Previously, the FDA granted StrataGraft orphan drug status, and it was among the first products designated by the agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act. 공고 • Jan 29
Mallinckrodt plc Receives Approval in Japan of the CELLEX® Extracorporeal Photopheresis System for Treatment of Chronic Graft Versus Host Disease Mallinckrodt plc announced that Japan's Ministry of Health, Labour and Welfare approved the CELLEX® extracorporeal photopheresis (ECP) system for the treatment of steroid-resistant or intolerant chronic graft versus host disease (cGvHD) in adults. The approval was based on an open-label study conducted in patients with steroid-resistant or intolerant cGvHD after allogeneic hematopoietic stem cell transplantation at three institutions in Japan. The efficacy rate following evaluation of response and changes in steroid dose 24-weeks after ECP initiation was 66.7 percent (8/12 patients), the primary endpoint of the study. Adverse events were observed in all patients (n=15, 106 events). Most of the adverse events observed were considered as those of the primary disease or associated with long-term treatment with steroids. There were no adverse events unique to this treatment. 공고 • Nov 11
Mallinckrodt plc Initiates Retrospective Study of the Use of Inhaled Nitric Oxide in Covid-19 Patients Mallinckrodt plc, announced initiation of a retrospective chart review study, titled Nitric Oxide Treatment In COVID-19 Evaluation to collect real-world data on the use of INOmax® (nitric oxide) gas, for inhalation therapy in patients with respiratory complications associated with the novel coronavirus SARS-CoV-2. INOmax is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. The safety and efficacy of INOmax to treat lung complications associated with COVID-19 has not been evaluated or established by the U.S. Food and Drug Administration. The primary objectives of the study are as follows: Describe the disease course in patients initiating INOmax for management of COVID-19 symptoms; Assess the clinical outcomes of patients who have received INOmax early (high P/F ratio or low OI) vs late (low P/F ratio or high OI); Describe the demographic and clinical characteristics of patients hospitalized with COVID-19 and treated with INOmax; Describe treatments and procedures, and during the initial hospitalization, and survival at 30 days post-discharge in patients who are treated with INOmax; Assess selected complications and adverse events as documented in the medical chart of initial hospitalization; Evaluate healthcare resource use during initial hospitalization. COVID-19 is a contagious respiratory illness caused by a novel coronavirus. Patients with COVID-19 have mild to severe respiratory illness that can include symptoms such as cough, fever and shortness of breath.1 In severe cases, COVID-19 can cause acute respiratory distress syndrome (ARDS) – a disorder in which fluid leaks into the lungs, making breathing difficult or impossible – and can lead to multi-organ failure and sometimes death. To date, more than 200,000 patients in the U.S. have died from COVID-19. INOmax has been on the market in the U.S. since 2000 and is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. Please see Important Safety Information below. The safety and efficacy of INOmax and iNO for pulmonary complications associated with COVID-19 have not been established. 공고 • Jul 10
Mallinckrodt plc to Report Q2, 2020 Results on Aug 04, 2020 Mallinckrodt plc announced that they will report Q2, 2020 results at 11:00 AM, GMT Standard Time on Aug 04, 2020