Oral Hemorrhage

Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that Health Canada has approved DOPTELET® (avatrombopag), an oral thrombopoietin receptor agonist (TPO-RA), for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment and for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure. ”The current treatment landscape for immune thrombocytopenia in Canada has left certain patients with limited options. With today’s approval of Doptelet, patients now have an effective oral treatment option with no food-type restrictions or need for liver function monitoring,” said Dr. Charles H. Li, MD, FRCPC, Consultant Hematologist at Vancouver General Hospital and Clinical Associate Professor at the University of British Columbia. ”Similarly, individuals with chronic liver disease have a new approach to raise their platelet count and optimize hemostasis before invasive procedures – one that avoids the exposure to, and the expenses associated with blood products, such as blood transfusions.” In adults, ITP lasting for more than one year is considered chronic.1 Approximately, 9.5 per 100,000 adults in the United States and Western Europe are living with ITP, with the condition being more common among younger adult women than men.1,2 “The approval of Doptelet means that certain people in Canada at increased risk of dangerous internal bleeding due to thrombocytopenia now have an option which, because it is taken with food, may be easier to incorporate into their daily routines,” said Bob McLay, Vice President, General Manager of Sobi Canada. “This treatment provides physicians with a new option for those living with thrombocytopenia – a condition in which the number of platelets that are critical for controlling bleeding is low.” The Health Canada approval of DOPTELET was supported by data from one Phase 3 trial and two Phase 2 trials in patients with chronic ITP and two international, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials, ADAPT-1 and ADAPT-2, in patients with CLD.3 In the pivotal Phase 3 study, DOPTELET administration resulted in a platelet count of at least 50,000 per µL at day eight of therapy in the majority of patients, with efficacy superior to placebo in maintaining platelet counts in the target range during the six-month treatment period. Pooled safety data for 128 patients with ITP support the safety and tolerability of DOPTELET. The most common treatment-emergent adverse events (TEAEs) (those occurring in ≥10% of patients) in the DOPTELET treatment group versus placebo were headache (31%), fatigue (28%), contusion (26%), epistaxis (19%), upper respiratory tract infection (15%), arthralgia (13%), gingival bleeding (13%), petechiae (11%) and nasopharyngitis (10%).3 In both the ADAPT-1 and ADAPT-2 trials, the proportion of patients not requiring a platelet transfusion or any rescue procedure for bleeding was significantly higher in the two DOPTELET-treated groups (low baseline platelet count and high baseline platelet count) than in the placebo group. Both trials demonstrated a higher proportion of patients who achieved the target platelet count of ≥50,000/µL on the day of procedure (a secondary efficacy endpoint) in both DOPTELET-treated groups versus the placebo-treated groups for both cohorts.3 Additionally, both trials demonstrated a greater mean change in platelet counts from baseline to the day of the procedure (a secondary efficacy endpoint) in both DOPTELET-treated groups versus the placebo-treated groups. A measured increase in platelet counts was observed in both DOPTELET-treated groups over time beginning on Day 4 post-dose, that peaked on Day 10-13, decreased seven days post-procedure, and then returned to near baseline values by Day 35.3 The majority of adverse events were mild to moderate in severity and consistent with what was expected in patients with CLD as supported by data from the placebo treatment group. The most common treatment-emergent adverse events (TEAEs) (those occurring in ≥3% of patients) in the DOPTELET-treated groups (60 mg or 40 mg) versus placebo, across the pooled data from the two trials, were pyrexia (10%), abdominal pain (7%), nausea (7%), headache (6%), fatigue (4%) and edema peripheral (3%)l.3 Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low numbers of platelets that results in an increased risk of bleeding. Symptoms can be highly variable and include bruising, a rash of small dots that represent small hemorrhages, bleeding from the gums or nose, blood in the urine/stools and debilitating fatigue. It is estimated that up to 100 people per million live with ITP. The disorder is considered chronic when symptoms last more than 12 months.4 Long-term, primary chronic ITP is associated with increased risk of infections, bleeding episodes requiring hospitalization, hematologic malignancies, and mortality. No cure is available, and patients with chronic ITP usually relapse after various treatments and still require treatment to reduce the risk of clinically significant bleeding. Thrombocytopenia is a common complication in patients with chronic liver disease (CLD), with the extent of thrombocytopenia often worsening with the severity of liver disease. Thrombopoietin (TPO), the principal physiologic regulator of platelet production, is produced primarily in the liver. TPO stimulates the production and differentiation of platelet-producing megakaryocytes in the bone marrow. Damage to the liver in patients with CLD can cause reduced TPO production and consequent decreased platelet production and thrombocytopenia. Patients with CLD who have a platelet count of less than 50,000/µL typically require one to three invasive diagnostic and therapeutic procedures per year. Each of these procedures carries a risk of bleeding. If not effectively treated, thrombocytopenia can lead to serious uncontrolled bleeding, resulting in prolonged hospitalizations and other post-procedure complications. DOPTELET is an orally bioavailable, small molecule thrombopoietin receptor agonist (TPO-RA) that stimulates the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in increased production of platelets. DOPTELET does not compete with TPO for binding to the TPO receptor. As the North American affiliate of international biopharmaceutical company Sobi, the Sobi North America team is committed to Sobi’s vision of providing access to innovative treatments that make a significant difference in the lives of individuals with rare diseases. Our product portfolio includes multiple approved treatments focused on immunology, hematology and specialty care. With U.S. headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. More information is available at https://www.sobi.com/canada or at www.sobi.com. Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of hematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2022, revenue amounted to SEK 18.8 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. 1 Lambert MP, Gernsheimer TB. Blood. 2017;129(21):2829-2835. 2 National Organization for Rare Disorders. Rare Disease Database. Immune thrombocytopenia. Accessed June 30, 2020. https://rarediseases.org/rare-diseases/immune-thrombocytopenia 3 DOPTELET® (avatrombopag) - Product Monograph. Stockholm, Sweden: Swedish Orphan Biovitrum AB; 2020. The content above comes from the network. if any infringement, please contact us to modify.

Better Preventative Care is within Reach with Proclaim Custom-Jet Oral Irrigator MOUNTAIN VIEW, Calif., Nov. 1, 2023 /PRNewswire/ -- Customized preventative health company Proclaim™, is calling for tech-forward dental practices to sign up to be one of the first to trial its breakthrough medical device, the Custom-Jet Oral Irrigator. This Preventative Health System is the world's first and only personalized and fully automated solution to provide users with a 360-degree deep clean at home. As a result, it's clinically proven to reduce the signs of gingivitis in just 7 seconds a day at the push of a button. Continue Reading Proclaim Custom-Jet Oral Irrigator is the world’s first and only personalized and fully automated solution to provide users with a 360-degree deep clean at home. As a result, it’s clinically proven to reduce the signs of gingivitis in just 7 seconds a day at the push of a button. Utilizing the latest in digital intraoral scanning – facilitated through Proclaim dental partners – and advanced 3D-printing technology, Proclaim designs each patient's custom mouthpiece with up to 60 precisely-placed pressurized jets along both facial and lingual interproximal sites. The jets send pulsing water between the teeth and below the gumline, providing a 360-degree deep-clean at the push of a button for consistent, effective results every time. Unlike existing manual solutions, this innovation was specially designed to offer patients a more sustainable and easier way to improve and maintain their oral health care habits at home, resulting in better preventative care. Dr. Steven Glassman, DDS and renowned cosmetic dentist to the stars, shared, "This device will truly revolutionize the guidance we can give our adult patients who are struggling with varying levels of gum disease, especially for those who find it difficult to maintain a proper oral care routine at home." Clinical trial patients using Proclaim showed significant reductions in plaque accumulation, gingival inflammation and bleeding, and improvements in both pocket depth and bleeding on probing compared to traditional tooth brushing and flossing. After 30 days of use, the overall results showed 82% reduction in gingival bleeding, 41% reduction in gingival inflammation, 23% reduction in pocket depth and 34% reduction in plaque accumulation. The published clinical trial results can be accessed here. Dr. Jonathan Nicozisis, DMD, MS, nationally recognized orthodontist and Invisalign expert, added, "The Proclaim experience is life changing for patients. It's the first oral care innovation I've seen in decades that combines cutting-edge technology with clinically proven effectiveness. And by customizing and automating the process, we're able to remove the barriers to better oral health that many of our patients face on a daily basis." Once a patient purchases Proclaim online, they are prompted to schedule an appointment for an intraoral scan at a dental partner location near them. This step is essential for 3D printing their custom mouthpiece. Once complete, the mouthpiece and Custom-Jet Oral Irrigator are shipped directly to the patient for immediate use. For a limited time, Proclaim is offering trial devices of the Custom-Jet Oral Irrigator for dental professionals who want to experience the difference for themselves. Learn more about becoming a Proclaim partner and sign up for your chance to receive an exclusive trial device at Professional.ProclaimHealth.com. The Custom-Jet Oral Irrigator will be shipping soon and trial quantities are limited. About Proclaim™ Founded in 2017 in Mountain View, California, Proclaim is a leading preventative health company committed to building innovative, tech-driven solutions that drastically improve the quality of daily oral care. Proclaim's Custom-Jet Oral Health System is a clinically proven at-home solution that effortlessly transforms the health of your entire mouth in just 30 days. Each system features a custom-fit mouthpiece with up to 60 precisely placed jets that pulse water between the teeth, providing a 360-deep clean that reaches below the gum line, all in just seven seconds. With the push of a button, Proclaim delivers a professional-level clean that has been shown to start reducing the signs of gum disease in as little as 15 days and is up to 13x more effective than flossing. For more information, visit Professional.ProclaimHealth.com. Methodology 192 adult subjects completed the 30-day randomized, examiner-blinded clinical trial, with 61 subjects randomly assigned to the control group (brushing only), 65 subjects randomly assigned to the brushing + floss group, and 66 subjects randomly assigned to the brushing + Proclaim Oral Care System group. All subjects were provided with an ADA reference soft manual toothbrush and ADA accepted fluoride toothpaste and were instructed to brush 2x daily according to their usual habits. Subjects in the Proclaim group visited the research site once daily to use the Custom-Jet Oral Irrigator at the maximum setting (with water). Those in the floss group were instructed to floss once daily at home. Gingivitis was assessed at six sites per tooth using the Modified Gingival Index (MGI) and bleeding on a marginal probing via Gingival Bleeding Index (GBI), and plaque was measured using the Rustogi Modified Navy Plaque Index (RMNPI). Additionally, periodontal probing depth (PPD) and bleeding on probing (BOP) were measured at six sites per tooth. The clinical trial referenced was conducted at Salus Research in Fort Wayne, Indiana, an ADA-qualified research site. SOURCE Proclaim

Global biopharma company encourages education and awareness around a rare bleeding disorder. FORT LEE, N.J., Oct. 10, 2023 /PRNewswire/ -- Kedrion Biopharma, an international biopharmaceutical company specializing in the production and distribution of plasma-derived therapeutic products used in treating rare and serious diseases, is proud to recognize the fourth Hereditary Factor X (10) Deficiency Awareness Day on October 10, 2023. This day helps bring awareness to a rare bleeding disorder, the patients it impacts, their challenges, and the treatments that can help. Continue Reading Factor X Day was launched on 10/1020 by U.K.-based Bio Products Laboratory (BPL). In 2022, Kedrion joined forces with BPL. The new Kedrion is a global player in plasma derivatives and rare disease medicines, employing more than 5,000 people worldwide. Kedrion Biopharma is proud to recognize the fourth Hereditary Factor X (10) Deficiency Awareness Day on October 10, 2023 Tweet this About one in a million people have hereditary factor X deficiency, which causes unusual or excessive bleeding or bruising, heavy menstrual bleeding in women, painful or swollen joints, nose bleeds, and bleeding gums. Although the disorder is ultra-rare, some patients with severe factor X deficiency could experience life-threatening complications like bleeding in the brain or stomach. Because symptoms vary, patients may suffer for years before being diagnosed. A simple blood test can determine whether someone has the disorder and can be treated with plasma-based treatments. John, one of the oldest known patients with severe hereditary factor X deficiency at age 51, says it best. "Since being diagnosed when I was a year old, I have had to go to the hospital about 150 times for transfusions of fresh frozen plasma to treat bleeds that were not controlled by themselves. As someone living with hereditary factor X deficiency, I want everyone to be more aware of this rare disease and why it is so important to get care and treatment." "We are excited for the first Hereditary Factor X Deficiency Awareness Day since Kedrion joined forces with Bio Products Laboratory in 2022," said Bob Rossilli, Chief Commercial Officer for Kedrion Biopharma. "With over 60 years of combined expertise across the United Kingdom, United States, and Italy, we are delighted to continue raising awareness for hereditary factor X deficiency and providing therapies to support patients, their caregivers, and families on the journey from diagnosis to treatment." Kedrion is committed to providing therapies for rare diseases to improve patients' health as they manage bleeding disorders like hereditary factor X deficiency. To learn more about hereditary factor X deficiency, visit . About Kedrion Kedrion Biopharma is a global biopharmaceutical company that collects and fractionates blood plasma to produce and distribute plasma-derived therapies for use in treating and preventing serious diseases, disorders, and conditions like plasminogen deficiency, hereditary factor X deficiency, and hemophilia. Its portfolio of 37 life-saving products is distributed in over 100 countries. kedrion.com Contact Information: Sandy Sklareski Communications Manager [email protected] 551-255-6557 SOURCE Kedrion Biopharma