Jump to content

Search the Community

Showing results for tags 'Benlysta'.



More search options

  • Search By Tags

    Type tags separated by commas.
  • Search By Author

Content Type


Forums

  • The LuPUS Message Board
    • Announcements
    • What is the LuPUS Message Board?
    • A Welcome to New Members
    • User Problems
    • Links
  • Medical
    • Medical News 2003
    • Medical News 2004
    • Medical News 2005
    • Medical News 2006
    • Medical News 2007
    • Medical News 2008
    • Medical News 2009
    • Medical News 2010
    • Medical News 2011
    • Medical News 2012
    • Medical News 2013
    • Medical News 2014
    • Medical News 2015
    • Medical News 2016
    • Medical News 2017
    • Medical News 2018
    • Medication & Therapy
    • Lupus and Pregnancy
    • Sjögren’s syndrome
  • Non-Medical
    • LuPUS Message Board
  • Public
    • Guest & Test Messages
    • Free Offers
    • Contributors

Blogs

  • Admin
  • Admin
  • Changes To My Diet For Health Reasons

Categories

There are no results to display.


Find results in...

Find results that contain...


Date Created

  • Start

    End


Last Updated

  • Start

    End


Filter by number of...

Joined

  • Start

    End


Group


AIM


MSN


Website URL


ICQ


Yahoo


Jabber


Skype


Location


Interests

Found 4 results

  1. Benlysta Formulation for Lupus Gets FDA Nod August 01, 2017 | Lupus By Rheumatology Network Staff A new subcutaneous formulation of Benlysta (belimumab) has received FDA approval for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy, GSK announced. This is the first subcutaneous self-injection treatment option for patients with SLE, according to GSK. Patients will be able to administer the medicine as a once-weekly injection of 200 mg, from a single-dose prefilled syringe or a single-dose autoinjector, after receiving training from their health care provider. This is the second formulation of Benlysta to be granted FDA approval for SLE, GSK noted. The intravenous formulation, approved in 2011, is administered to patients as a weight-based dose of 10 mg/kg, via a 1-hour infusion in a hospital or clinic setting every 4 weeks (after an initial loading phase given on days 0, 14, and 28). “Lupus can impact the lives of patients in many different ways with varied and often unpredictable symptoms,” said Vlad Hogenhuis, GSK’s Senior Vice President, Head of Specialty Care. “Since it launched in its IV form, thousands of patients worldwide have received treatment with Benlysta. The approval of the new injectable formulation will now provide an additional choice for patients, allowing them to self-administer their medicine at home rather than going to hospitals or clinics for their infusions.” The approval is based on data from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE. The study measured reduction in disease activity at Week 52 in patients receiving belimumab plus standard of care versus those receiving placebo plus standard of care (assessed by the SLE Responder Index). The Benlysta subcutaneous formulation will be available in specialty pharmacies in the United States in late August. Further regulatory submissions for the subcutaneous formulation of Benlysta are under review or planned in other countries during the course of 2017.
  2. GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus Issued: London, UK GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus GSK announced today that the US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody‑positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus (SLE) is the most common form of lupus, a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body. The approval marks the first subcutaneous self-injection treatment option for patients with SLE. After training from their health care provider, patients will be able to administer the medicine as a once weekly injection of 200mg, from either a single-dose prefilled syringe or from a single-dose autoinjector. This is the second formulation of Benlysta to be granted approval for SLE, adding to the existing intravenous (IV) formulation, approved in 2011, which is administered by healthcare professionals to patients as a weight-based dose of 10mg/kg, via a one-hour infusion in a hospital or clinic setting every four weeks (following an initial loading phase given on days 0, 14 and 28). Vlad Hogenhuis, Senior Vice President, Head of Specialty Care, GSK said, “We are delighted with today’s decision. Lupus can impact the lives of patients in many different ways with varied and often unpredictable symptoms. Since it launched in its IV form, thousands of patients worldwide have received treatment with Benlysta. The approval of the new injectable formulation will now provide an additional choice for patients, allowing them to self-administer their medicine at home rather than going to hospitals or clinics for their infusions.” The approval is based on data from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE, which measured reduction in disease activity at Week 52 in patients receiving belimumab plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus). Benlysta subcutaneous formulation will be available in specialty pharmacies in the US in late August. Further regulatory submissions for the subcutaneous formulation of Benlysta are under review or planned in other countries during the course of 2017. About Benlysta (belimumab) Benlysta is currently the only medicine specifically developed and approved for SLE. Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Benlysta does not bind B cells directly. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Benlysta is indicated in the US for the treatment of adult patients with active, autoantibody‑positive, systemic lupus erythematosus (SLE) who are receiving standard therapy: Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations. Full US prescribing information including Medication Guide will be available in the near future at: gsksource.com. In the meantime, you may request a copy through GSK Communications. Benlysta is licensed in the European Union as an add-on therapy in adult patients with active autoantibody-positive SLE, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy. Benlysta subcutaneous formulation is currently not approved in the European Union. For the EU Summary of Product Characteristics for Benlysta, please visit www.ema.europa.eu About systemic lupus erythematosus (SLE) Systemic lupus erythematosus (SLE) is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide. Approximately 170,000-200,000 Americans live with SLE. It is a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body. Important Safety Information for belimumab Please consult the full Prescribing Information for all the labelled safety information for Benlysta (belimumab). BENLYSTA (belimumab): CONTRAINDICATION BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab. WARNINGS AND PRECAUTIONS MORTALITY There were more deaths reported with BENLYSTA than with placebo during the controlled period of the intravenous clinical trials. Out of 2,133 patients in 3 clinical trials, a total of 14 deaths occurred during the placebo-controlled, double-blind treatment periods: 3/675 (0.4%), 5/673 (0.7%), 0/111 (0%), and 6/674 (0.9%) deaths in the groups receiving placebo, BENLYSTA 1 mg/kg, BENLYSTA 4 mg/kg, and BENLYSTA 10 mg/kg, respectively. Etiologies included infection, cardiovascular disease, and suicide. In the controlled clinical trial of BENLYSTA administered subcutaneously (N = 836), a total of 5 deaths occurred during the placebo-controlled, double-blind treatment period (0.7% [2/280] of patients receiving placebo and 0.5% [3/556] of patients receiving BENLYSTA). Infection was the most common cause of death. SERIOUS INFECTIONS Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. Caution should be exercised when considering use in patients with severe or chronic infections. Consider interrupting therapy with BENLYSTA in patients who develop a new infection while receiving BENLYSTA and monitor these patients closely. In controlled clinical trials of BENLYSTA administered intravenously, serious infections occurred in 6.0% and 5.2% of patients receiving BENLYSTA and placebo, respectively. The most frequent serious infections included pneumonia, urinary tract infection, cellulitis, and bronchitis. Infections leading to discontinuation of treatment occurred in 0.7% and 1.0% of patients receiving BENLYSTA and placebo, respectively. Infections resulting in death occurred in 0.3% (4/1,458) and 0.1% (1/675) of patients receiving BENLYSTA and placebo, respectively. In the controlled trials of BENLYSTA administered subcutaneously (N = 836), serious infections occurred in 4.1% and 5.4% of patients receiving BENLYSTA and placebo, respectively. Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. Risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function. Consider the diagnosis of PML in any patient presenting with new-onset or deteriorating neurological signs and symptoms and consult with a neurologist or other appropriate specialist as clinically indicated. In patients with confirmed PML, consider stopping immunosuppressant therapy, including BENLYSTA. HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) Acute hypersensitivity reactions, including anaphylaxis and death, have been reported in association with BENLYSTA. These events generally occurred within hours of the infusion; however, they may occur later. Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema have been reported and typically occurred up to a week following the most recent infusion. Hypersensitivity, including serious reactions, has occurred in patients who have previously tolerated infusions of BENLYSTA. Limited data suggest that patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. In the controlled clinical trials of BENLYSTA administered intravenously, hypersensitivity reactions occurring on the day of the infusion were reported in 13% (191/1,458) and 11% (76/675) of patients receiving BENLYSTA and placebo, respectively. Anaphylaxis was observed in 0.6% (9/1,458) and 0.4% (3/675) of patients receiving BENLYSTA and placebo, respectively. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea. Some patients (13%) received premedication, which may have mitigated or masked a hypersensitivity response. There is insufficient evidence to determine whether premedication diminishes the frequency or severity of these reactions. Healthcare providers should be aware of the risk of hypersensitivity reactions and be prepared to manage anaphylaxis. In the event of a serious hypersensitivity reaction, discontinue BENLYSTA immediately and administer appropriate medical therapy. Patients should be monitored during and for an appropriate period of time after the intravenous administration of BENLYSTA. Patients receiving BENLYSTA should be informed of the signs and symptoms of an acute hypersensitivity reaction, and be instructed to seek immediate medical care should a reaction occur. In the controlled trial of BENLYSTA administered subcutaneously (N = 836), the incidence and severity of systemic hypersensitivity reactions were similar to those observed in the intravenous clinical trials. INFUSION REACTIONS In the controlled clinical trials, infusion reactions occurring on the day of the infusion were reported in 17% (251/1,458) and 15% (99/675) of patients receiving BENLYSTA and placebo, respectively. Serious infusion reactions (excluding hypersensitivity reactions) were reported in 0.5% and 0.4% of patients receiving BENLYSTA and placebo, respectively. Serious infusion reactions included bradycardia, myalgia, headache, rash, urticaria, and hypotension. The most common infusion reactions occurring in ≥3% of patients receiving BENLYSTA were headache, nausea, and skin reactions. Some patients (13%) received premedication, which may have mitigated or masked an infusion reaction; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of these reactions. BENLYSTA should be administered by healthcare providers prepared to manage infusion reactions. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. Healthcare providers should be aware of the risk of hypersensitivity reactions, which may present as infusion reactions, and monitor patients closely. DEPRESSION In controlled clinical trials of BENLYSTA administered intravenously, serious psychiatric events were reported in 0.8% and 0.4% of patients receiving BENLYSTA and placebo, respectively. Serious depression was reported in 0.4% and 0.1% of patients receiving BENLYSTA and placebo, respectively. Two suicides were reported in patients receiving BENLYSTA. In the controlled trial of BENLYSTA administered subcutaneously, serious psychiatric events were reported in 0.2% of patients receiving BENLYSTA and in no patients receiving placebo. It is unknown if treatment with BENLYSTA is associated with increased risk for these events. Instruct patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes. MALIGNANCY The impact of treatment with BENLYSTA on the development of malignancies is not known. The mechanism of action of BENLYSTA could increase the risk for the development of malignancies. IMMUNIZATION Live vaccines should not be given for 30 days before or concurrently with BENLYSTA. BENLYSTA may interfere with the response to immunizations. USE WITH BIOLOGIC THERAPIES OR IV CYCLOPHOSPHAMIDE BENLYSTA has not been studied in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide. Therefore, use of BENLYSTA is not recommended in combination with these therapies. ADVERSE REACTIONS Intravenous administration Adverse reactions, regardless of causality, occurring in at least 3% of patients with SLE who received BENLYSTA 10 mg/kg and placebo respectively and, at an incidence at least 1% greater than that observed with placebo in the 3 controlled studies, were: nausea 15% and 12%; diarrhea 12% and 9%; pyrexia 10% and 8%; nasopharyngitis 9% and 7%; bronchitis 9% and 5%; insomnia 7% and 5%; pain in extremity 6% and 4%; depression 5% and 4%; migraine 5% and 4%; pharyngitis 5% and 3%; cystitis 4% and 3%; leukopenia 4% and 2%; viral gastroenteritis 3% and 1%. Subcutaneous administration The safety profile observed for BENLYSTA administered subcutaneously was consistent with the known safety profile of BENLYSTA administered intravenously, with the exception of local injection site reactions, which occurred in 6.1% and 2.5% of patients receiving BENLYSTA and placebo, respectively. OTHER IMPORTANT INFORMATION FOR BENLYSTA USE IN SPECIFIC POPULATIONS Pregnancy: There are insufficient data on use of BENLYSTA in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Following an assessment of benefit versus risk, if prevention is warranted, women of childbearing potential should use effective contraception during treatment and for at least 4 months after the final treatment. Lactation: There is no information available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BENLYSTA and any potential adverse effects on the breastfed child from BENLYSTA or from the underlying maternal condition. Black/African American Patients: In controlled clinical trials of BENLYSTA administered intravenously, SLE Responder Index-4 (SRI-4) response rates were lower for black/African American patients receiving BENLYSTA relative to black/African American patients receiving placebo. In the controlled trial of BENLYSTA administered subcutaneously, SRI-4 response was slightly higher for black/African American patients receiving BENLYSTA relative to black/African American patients receiving placebo, but the treatment difference was not as great as that observed in the overall population. Use with caution in black/African American patients. Populations not studied Benlysta has not been studied in the following patient groups, and is not recommended in patients with: ∙ severe active central nervous system lupus ∙ severe active lupus nephritis ∙ HIV ∙ a history of, or current, hepatitis B or C ∙ hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl) ∙ a history of major organ transplant or hematopoietic stem /cell /marrow transplant or renal transplant.
  3. Benlysta: first targeted lupus treatment 01 November 2011, 9:14am Benlysta (belimumab) is licensed as add-on therapy in patients with autoantibody-positive systemic lupus erythematosus (SLE) who have high disease activity despite standard treatment. Benlysta must be administered in hospital PHARMACOLOGY Belimumab is a monoclonal antibody specific for the soluble human B lymphocyte stimulator protein, BLyS. It inhibits the differentiation of B cells into antibody-producing plasma cells.1 CLINICAL STUDIES Two pivotal randomised trials showed that the addition of belimumab to standard care improves control of disease activity in SLE. BLISS-76 and BLISS-52 enrolled seropositive SLE patients (n=819 and n=865, respectively). In addition to standard treatment, patients received belimumab 10mg/kg or 1mg/kg or placebo by intravenous infusion on days 0, 14 and 28, and every 28 days thereafter.2,3 In both studies, response rates at week 52 (as determined by the SLE Responder Index) were significantly higher in patients treated with the 10mg/kg dose of belimumab than in patients who received placebo. In a pooled analysis of the two studies, the combined response rate was 51% for belimumab 10mg/kg compared with 39% for placebo (p<0.0001).2,3 Belimumab was well tolerated in both studies, with rates of adverse events similar to placebo.2,3 REFERENCES Benlysta Summary of Product Characteristics, July 2011. Furie R et al. Arthritis Rheum 2011, Accepted article; DOI: 10.1002/art.30613. Navarra SV et al. Lancet 2011; 377: 721–31. View Benlysta drug record Further information: GlaxoSmithKline
  4. NICE draft guidance provisionally denies funding for lupus treatment Benlysta on the NHS Posted 05.10.2011 Draft guidance issued last Friday by the National Institute for Health and Clinical Excellence (NICE) does not recommend Benlysta (belimumab) for patients with active autoantibody positive systemic lupus erythematosus (SLE) in England and Wales because it does not consider it to be a cost-effective use of National Health Service (NHS) resources. Belimumab was granted marketing authorisation by the European Commission in July 2011 in adult patients with SLE, with a high degree of disease activity, despite standard therapy. It is the first new treatment to be specifically developed and licensed for use in these patients for several decades and is reflective of GSK's commitment to researching and developing innovative medicines in diseases of high unmet need. Simon Jose, General Manager, GlaxoSmithKline UK, commented: "Today's initial decision is very disappointing for patients living with lupus who currently have very limited treatment options and we will do everything we can to change NICE's mind in an effort to ensure they get access to Benlysta on the NHS." "NICE's current methodology means that it is difficult to meet their cost-effectiveness threshold given the nature of the disease and the comparison with unlicensed or cheap generic medicines. We had hoped that our offer of a patient access scheme would help overcome these challenges." "It is critically important that the current limitations are addressed quickly so patients in England and Wales can get access to the best medicines for their conditions," he added. The draft guidance in the NICE Appraisal Consultation Document (ACD) is open to comment from interested parties, including physicians and the general public, on the NICE website ( www.nice.org.uk) until 21 October 2011, when the consultation period ends. Benlysta is a registered trademark owned by Human Genome Sciences, Inc., used under license by the GlaxoSmithKline group of companies. http://hcp.gsk.co.uk/therapyareas/musculoskeletal/benlysta/product_news/nice_draft_guidance_provisionally_denies_funding_for_lupus_treatment_benlysta_on_the_nhs/
×