BREDA, the Netherlands–(BUSINESS WIRE)– Regulatory Information:
argenx SE (Euronext & Nasdaq: ARGX), a world immunology firm dedicated to enhancing the lives of individuals affected by extreme autoimmune illnesses, at present introduced that interim information can be offered from ADAPT+ on the American Academy of Neurology (AAN) Annual Assembly in Seattle, WA, April 2-7. ADAPT+ is the worldwide Part 3 open-label extension research evaluating long-term efficacy, security and tolerability of VYVGART® (efgartigimod alfa-fcab) in grownup sufferers with generalized myasthenia gravis (gMG).
Further shows at AAN will embrace a evaluate of baseline traits from the Firm’s pre-approval entry program for VYVGART, in addition to information on the remedy burden of gMG from a cross-sectional research of 152 U.S. adults with a self-reported gMG analysis.
“We’re thrilled that our ADAPT+ research has been chosen for an oral presentation at this essential neurology discussion board, and hope these thrilling information will advance healthcare suppliers’ understanding of long-term therapeutic outcomes with VYVGART as they proceed to handle their gMG sufferers,” stated Tim Van Hauwermeiren, Chief Govt Officer of argenx. “We stay as dedicated as ever to the gMG group, and look towards to providing deeper perception into the affected person expertise so we could greatest tackle their unmet wants and search to alleviate the burden of this complicated, debilitating illness.”
AAN 2022 Shows:
Long-term Safety, Tolerability, and Efficacy of Efgartigimod in Patients with Generalized Myasthenia Gravis: Interim Results of the ADAPT+ Study
Tuesday, April 5, 2022, at 4:06 PM PT
Session: S25: Autoimmune Neurology 2: Scientific Trials and Therapy; Presentation 004
Presenter: James F. Howard Jr., M.D., Professor of Neurology (Neuromuscular Illness), Medication and Allied Well being, Division of Neurology, The College of North Carolina at Chapel Hill College of Medication
Baseline Characteristics and Demographics of Patients Enrolled in an Expanded Access Program for Efgartigimod in Adult Patients with Generalized Myasthenia Gravis
Saturday, April 2, 2022 from 5:30 PM – 6:30 PM PT
Session: P3: Autoimmune Neurology: Peripheral Nervous System and Muscle 1; Presentation 001, Neighborhood 1
Presenter: Deborah Gelinas, M.D., Govt Director, Neuromuscular Medical Affairs, argenx
Treatment Burden According to Patients with Generalized Myasthenia Gravis
Sunday, April 3, 2022 from 5:30 PM – 6:30 PM PT
Session: P6: Neuromuscular Illness: Myasthenia Gravis 1; Presentation 008, Neighborhood 13
Presenter: Tuan Vu, M.D., Professor of Neurology, College of South Florida
The assembly abstracts can be found on-line and will be accessed via the AAN assembly web site at AAN.com. To study extra about VYVGART, please go to AAN Sales space #317 or VYVGART.com.
See the total Prescribing Information for VYVGART within the U.S., which incorporates the beneath Vital Security Data. For extra data associated to VYVGART in Japan, go to argenx.jp.
IMPORTANT SAFETY INFORMATION FOR VYVGART® (efgartigimod alfa-fcab) intravenous (IV) formulation (U.S. PRESCRIBING INFORMATION)
What’s VYVGART® (efgartigimod alfa-fcab)?
VYVGART is a prescription drugs used to deal with a situation known as generalized myasthenia gravis, which causes muscle tissues to tire and weaken simply all through the physique, in adults who’re constructive for antibodies directed towards a protein known as acetylcholine receptor (anti-AChR antibody constructive).
What’s crucial data I ought to find out about VYVGART?
VYVGART could trigger severe negative effects, together with:
- An infection. VYVGART could improve the chance of an infection. In a medical research, the commonest infections had been urinary tract and respiratory tract infections. Extra sufferers on VYVGART vs placebo had beneath regular ranges for white blood cell counts, lymphocyte counts, and neutrophil counts. The vast majority of infections and blood negative effects had been delicate to average in severity. Your well being care supplier ought to test you for infections earlier than beginning remedy, throughout remedy, and after remedy with VYVGART. Inform your well being care supplier when you have any historical past of infections. Inform your well being care supplier instantly when you have indicators or signs of an an infection throughout remedy with VYVGART equivalent to fever, chills, frequent and/or painful urination, cough, ache and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, extra phlegm, nasal discharge, again ache, and/or chest ache.
- Undesirable immune reactions (hypersensitivity reactions). VYVGART may cause the immune system to have undesirable reactions equivalent to rashes, swelling below the pores and skin, and shortness of breath. In medical research, the reactions had been delicate or average and occurred inside 1 hour to three weeks of administration, and the reactions didn’t result in VYVGART discontinuation. Your well being care supplier ought to monitor you throughout and after remedy and discontinue VYVGART if wanted. Inform your well being care supplier instantly about any undesirable reactions.
Earlier than taking VYVGART, inform your well being care supplier about all your medical situations, together with when you:
- Have a historical past of an infection otherwise you suppose you have got an an infection
- Have acquired or are scheduled to obtain a vaccine (immunization). Talk about together with your well being care supplier whether or not it is advisable obtain age-appropriate immunizations earlier than initiation of a brand new remedy cycle with VYVGART. The usage of vaccines throughout VYVGART remedy has not been studied, and the protection with stay or live-attenuated vaccines is unknown. Administration of stay or live-attenuated vaccines just isn’t really useful throughout remedy with VYVGART.
- Are pregnant or plan to turn into pregnant and are breastfeeding or plan to breastfeed.
Inform your well being care supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements.
What are the frequent negative effects of VYVGART?
The commonest negative effects of VYVGART are respiratory tract an infection, headache, and urinary tract an infection.
These aren’t all of the attainable negative effects of VYVGART. Name your physician for medical recommendation about negative effects. You might report negative effects to the US Meals and Drug Administration at 1-800-FDA-1088.
Please see the total Prescribing Information for VYVGART and discuss to your physician.
About Efgartigimod
Efgartigimod is an antibody fragment designed to scale back pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling course of. Efgartigimod is being investigated in a number of autoimmune illnesses recognized to be mediated by disease-causing IgG antibodies, together with neuromuscular issues, blood issues, and pores and skin blistering illnesses. Efgartigimod is at present permitted in america as VYVGART® (efgartigimod alfa-fcab) for the remedy of adults with generalized myasthenia gravis (gMG) who’re anti-acetylcholine receptor (AChR) antibody constructive and in Japan for the remedy of adults with gMG who don’t have ample response to steroids or non-steroidal immunosuppressive therapies (ISTs).
About Generalized Myasthenia Gravis
Generalized myasthenia gravis (gMG) is a uncommon and continual autoimmune illness the place immunoglobulin G (IgG) autoantibodies disrupt communication between nerves and muscle tissues, inflicting debilitating and probably life-threatening muscle weak spot. Roughly 85% of individuals with MG progress to gMG inside 24 months1, the place muscle tissues all through the physique could also be affected. Sufferers with confirmed AChR antibodies account for roughly 85% of the entire gMG inhabitants1.
About argenx
argenx is a world immunology firm dedicated to enhancing the lives of individuals affected by extreme autoimmune illnesses. Partnering with main tutorial researchers via its Immunology Innovation Program (IIP), argenx goals to translate immunology breakthroughs right into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and-only permitted neonatal Fc receptor (FcRn) blocker within the U.S. and Japan. The Firm is evaluating efgartigimod in a number of severe autoimmune illnesses and advancing a number of earlier stage experimental medicines inside its therapeutic franchises. For extra data, go to www.argenx.com and observe us on LinkedIn, Twitter, and Instagram.
References
- Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
Ahead-looking Statements
The contents of this announcement embrace statements which can be, or could also be deemed to be, “forward-looking statements.” These forward-looking statements will be recognized by means of forward-looking terminology, together with the phrases “believes,” “hope,” “estimates,” “anticipates,” “expects,” “intends,” “could,” “will,” or “ought to” and embrace statements argenx makes regarding the anticipated long-term security, tolerability and efficacy of VYVGART® (efgartigimod alfa-fcab) in grownup sufferers with generalized myasthenia gravis. By their nature, forward-looking statements contain dangers and uncertainties and readers are cautioned that any such forward-looking statements aren’t ensures of future efficiency. argenx’s precise outcomes could differ materially from these predicted by the forward-looking statements on account of varied essential elements. An additional record and outline of those dangers, uncertainties and different dangers will be present in argenx’s U.S. Securities and Alternate Fee (SEC) filings and experiences, together with in argenx’s most up-to-date annual report on Type 20-F filed with the SEC in addition to subsequent filings and experiences filed by argenx with the SEC. Given these uncertainties, the reader is suggested to not place any undue reliance on such forward-looking statements. These forward-looking statements converse solely as of the date of publication of this doc. argenx undertakes no obligation to publicly replace or revise the knowledge on this press launch, together with any forward-looking statements, besides as could also be required by regulation.
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