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argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy | ||
By: GlobeNewswire - 20 Feb 2024 | Back to overview list |
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Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2024 If approved, VYVGART® Hytrulo will be the first neonatal Fc receptor (FcRn) blocker to treat CIDP February 20, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The application has been granted a PDUFA target action date of June 21, 2024. “Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx. “CIDP is yet another example of an autoimmune disease that has not been well understood, and for which there has been insufficient innovation for patients. We chose to use a priority review voucher to accelerate review of our submission because CIDP patients have long been waiting for new treatment options. FDA’s acceptance of the sBLA represents an important milestone in our continued drive to bring novel treatments for rare, autoimmune diseases, and a significant step forward for people whose lives have been profoundly impacted by this devastating disease.” The sBLA is supported by data from the ADHERE study, the largest clinical trial of CIDP to date, evaluating the safety and efficacy of subcutaneously administered VYVGART Hytrulo in adults with CIDP. The study met its primary endpoint (p=0.000039), demonstrating a 61% lower risk of relapse (HR: 0.39 95% CI: 0.25; 0.61) with VYVGART Hytrulo compared to placebo. In the open-label Stage A of the study, 67% of patients showed evidence of clinical improvement (ECI) following treatment with VYVGART Hytrulo. Given the mechanism of action of VYVGART Hytrulo as an FcRn blocker, the clinical results established that IgG autoantibodies play a significant role in the underlying biology of CIDP. VYVGART Hytrulo was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART®. After completing ADHERE, 99% of eligible patients (226/228) continued to the ADHERE-+ open-label extension study. About Chronic Inflammatory Demyelinating Polyneuropathy About VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions. See FDA-approved Important Safety Information below and full Prescribing Information for VYVGART Hytrulo for additional information Important Safety Information What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)? VYVGART HYTRULO is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). IMPORTANT SAFETY INFORMATION What is the most important information I should know about VYVGART HYTRULO? VYVGART HYTRULO may cause serious side effects, including:
Before taking VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. What are the common side effects of VYVGART HYTRULO? The most common side effects of efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects of VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives. These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor. About argenx Contacts Media: Ben Petok Investors: Alexandra Roy (US) Lynn Elton (EU) Forward-Looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “plans,” “aims,” “believes,” “continues,” “hope,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” “should,” or “commitment” and include statements argenx makes concerning our advancement towards the delivery of VYVGART Hytrulo to CIDP patients, our continued drive to bring novel treatments for rare, autoimmune diseases, and our goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of our PDUFA review for VYVGART Hytrulo to CIDP patients, expectations regarding the inherent uncertainties associated with development of novel drug therapies, preclinical and clinical trial and product development activities and regulatory approval requirements, the acceptance of our products and product candidates by our patients as safe, effective and cost-effective, and the impact of governmental laws and regulations on our business. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. # # # |
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