Psoriatic Arthritis Misdiagnosis: Diseases PsA Can Be Mistaken For
Intravenous Formulation Of Biosimilar Tyenne Now Available
Tyenne® (tocilizumab-aazg), a biosimilar to Actemra® (tocilizumab), is now available in an intravenous (IV) presentation (80mg/4mL, 200mg/10mL, and 400mg/20mL single-dose vials for further dilution prior to IV infusion).
Tyenne, an interleukin-6 receptor antagonist, is indicated for the treatment of:
A biosimilar is a biological product that is approved based on a demonstration that it is highly similar to an already-approved biological product with no clinically meaningful differences in safety and efficacy from the reference product.
In March 2024, Tyenne received approval from the Food and Drug Administration for both IV and subcutaneous (SC) administration based on data from a phase 3 study (ClinicalTrials.Gov Identifier: NCT04512001). The trial compared tocilizumab-aazg to an EU-approved tocilizumab in patients with moderately to severely active rheumatoid arthritis. Findings showed both products were equally effective and safe.
The SC presentations of Tyenne are expected to launch later this year.
References:
Fresenius accelerates momentum in its (Bio)Pharma Business and launches Tyenne®, its Third Approved Biosimilar in the US. News release. Fresenius Kabi. April 15, 2024. Https://www.Businesswire.Com/news/home/20240415467178/en/Fresenius-Accelerates-Momentum-in-its-Bio-Pharma-Business-and-Launches-Tyenne%C2%AE-its-Third-Approved-Biosimilar-in-the-U.S.
Mercy Medical Center Dr. Wright Discusses Rheumatoid Arthritis In Women
Mercy Medical Center Dr. Wright discusses Rheumatoid Arthritis in women
Updated: 3:20 PM EDT Apr 27, 2024
RHEUMATOID ARTHRITIS SYMPTOMS CAN BE SIMILAR FOR BOTH MEN AND WOMEN. BUT NOW RESEARCH IS SHOWING THAT WOMEN HAVE MORE SEVERE SYMPTOMS. AND JOINING US NOW WITH MORE INFORMATION IS DOCTOR ERNESTINE WRIGHT FROM MERCY MEDICAL CENTER. THANKS FOR BEING HERE. GOOD MORNING. THANK YOU FOR HAVING ME. SO TELL ME WHY IS IT MORE SEVERE IN WOMEN? RHEUMATOID ARTHRITIS IS MORE SEVERE AND MORE COMMON IN WOMEN THAN MEN. IT'S THOUGHT THAT WOMEN HAVE A STRONGER AUTOIMMUNE SYSTEM, AND THEREFORE THEY'RE MORE LIKELY TO DEVELOP AUTO ANTIBODIES, AND THEREFORE AUTOIMMUNE CONDITIONS LIKE RHEUMATOID ARTHRITIS ARE A LOT MORE COMMON IN WOMEN THAN IN MEN. AND IT'S ALSO COMPLICATED. BUT ESTROGEN IS THOUGHT TO PLAY A ROLE IN THE DEVELOPMENT OF RHEUMATOID ARTHRITIS. WE FIND OUT THAT PREGNANT WOMEN DON'T TEND TO GET RHEUMATOID ARTHRITIS, BUT THEN THEIR RISK OF DEVELOPING RA INCREASES, PARTICULARLY IN THE FIRST YEAR AFTER HAVING A BABY. AND IT'S ALSO KNOWN THAT IN POSTMENOPAUSAL WOMEN WITH A DROP IN ESTROGEN LEVELS, THE DISEASE IS A LOT MORE SEVERE AND MORE CRIPPLING. SO WHAT ARE SOME OF THE SYMPTOMS? WELL, RHEUMATOID ARTHRITIS TENDS TO CAUSE INFLAMMATION, USUALLY IN THE SMALLER JOINTS OF THE BODY. THE HANDS AND THE TOES AND THE FEET. BUT IT ALSO AFFECTS OTHER AREAS OF THE BODY. IT CAN AFFECT YOUR HEART AND CAUSE A PERICARDITIS. IT CAN CAUSE INFLAMMATION IN THE LUNGS AND SHORTNESS OF BREATH. AND SO IT TENDS TO BE A MULTIFACTORIAL DISEASE. SO WHAT ARE SOME OF THE TESTS? I'M SORRY I'M JUST LIKE SO CURIOUS NOW IF IT AFFECTS ALL THOSE DIFFERENT PARTS OF YOUR BODY INTERNALLY AND THEN WITH YOUR JOINTS, HOW DO YOU TEST FOR THIS? WELL, IF YOU'RE EXPERIENCING JOINT SYMPTOMS, PARTICULARLY LIKE STIFFNESS IN THE MORNING THAT LASTS FOR MORE THAN 30 MINUTES, YOU SHOULD SEE A PRIMARY CARE PHYSICIAN. THERE ARE ACTUALLY BLOOD TESTS THAT CAN BE DONE TO LOOK FOR THESE AUTOIMMUNE ANTIBODIES. AND IF YOU'RE POSITIVE FOR AUTOIMMUNE ANTIBODIES, THEN YOUR PRIMARY CARE PHYSICIAN CAN REFER YOU TO A RHEUMATOLOGY JUST FOR TREATMENT AND WHAT WOULD TREATMENT BE? MEDICATIONS. WELL, THERE ARE DIFFERENT WAYS OF TREATING RHEUMATOID ARTHRITIS. THERE ARE THINGS THAT YOU CAN DO FOR YOURSELF, BECAUSE WE KNOW THAT OBESITY, SMOKING, GUM DISEASE AND CERTAIN FOODS TEND TO BE MORE INFLAMMATORY THAN OTHERS. AND SO IT'S IMPORTANT THAT SAY YOU CHANGE THE WAY YOU EAT AND HAVE MORE FRUITS AND VEGETABLES AND THINGS LIKE TURMERIC AND GINGER, WHICH ARE ANTI-INFLAMMATORY KHIREE. IT'S IMPORTANT TO EXERCISE REGULARLY TO MAINTAIN A HEALTHY WEIGHT, AND TO QUIT SMOKING AND MAKE SURE THAT THAT YOU SEE A DENTIST REGULARLY TO PREVENT GUM DISEASE. THEN THERE ARE DISEASES THAT ACTUALLY TREAT THE INFLAMMATION AND SWELLING IN THE JOINTS. UM, LIKE ANTI-INFLAMMATORIES AND PREDNISONE. AND THEN THERE ARE ALSO DISEASE MODIFYING AGENTS THAT RHEUMATOLOGISTS CAN PRESCRIBE TO ACTUALLY DECREASE YOUR LEVEL OF AUTOANTIBODIES SO THAT YOU DON'T CONTINUE TO HAVE FLARE UP OF THE DISEASE. DOCTOR. RIGHT. THANKS FOR COMING IN. I APPRECIATE IT. THANK YOU VERY MUCH. THANK YOU FOR HAVING ME. YOU ARE VERY WELCOME. AND IF YOU HAVE ANY OTHER QUESTION
Mercy Medical Center Dr. Wright discusses Rheumatoid Arthritis in women
Updated: 3:20 PM EDT Apr 27, 2024
Jennifer Franciotti speaks with Mercy Medical Center Dr. Ernestine Wright to discuss Rheumatoid Arthritis in women and the symptom's you should look out for.
BALTIMORE —Jennifer Franciotti speaks with Mercy Medical Center Dr. Ernestine Wright to discuss Rheumatoid Arthritis in women and the symptom's you should look out for.
Biogen's Tofidence Gets Positive CHMP Opinion For Rheumatoid Arthritis,Juvenile Arthritis & COVID-19
(RTTNews) - Biogen Inc. (BIIB) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA adopted a positive opinion for Tofidence (tocilizumab), a biosimilar monoclonal antibody referencing Roactemra.
The intravenous formulation of Tofidence has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for Tofidence.
If a marketing authorization is granted by the European Commission, Tofidence will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe. They are Benepali (etanercept), Imraldi (adalimumab) and Flixabi (infliximab).
Biogen and Bio-Thera reached a commercialization and licensing agreement for Tofidence (BAT1806/BIIB800) in April 2021. As per the deal, Tofidence, developed by Bio-Thera, is to be commercialized by Biogen in the European Union. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to Tofidence in all countries excluding China (including Hong Kong, Macau and Taiwan).
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