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The FDA approves the VYVGART HYTRULO itself for rare neurological diseases.

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San Diego,,, April 10, 2025 / Prnewswire/ -Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) announced today that Argenx received. Us VYVGART’s Food Pharmacy (FDA) approval® Hytrulo is a self-injection (EFGARTIGIMOD ALFA and EFGARTIGIMOD ALFA and for the treatment of adult patients with generalized severe gravis (GMG), an adult patient with anti-acetylcholine receptor (ACHR) antibody (ACHR) antibody (adult patients with adults with adult patients with chronic inflammatory agility polyphygo fat Hyaluronidase-QVFC) prejudice.

VYVGART® Preemptive syringes for self-injection are approved by the 20-30 seconds subcutaneous injection managed by patients, caregivers or medical professionals. The patient can self -injected after making appropriate instructions for subcutaneous injection techniques.

Single capacity subcutaneous injections have been developed as part of a dedicated partnership between ArgenX and Halozyme.® Drug delivery technology that enables rapid and mass delivery of biological preparations

Dr. Helen Torley, president and chief executive of Halozyme, said, “The FDA approval of VYVGART HYTRULO Prefilled syringe shows a significant development of treatment options for GMG and CIDP patients, and patients can manage and potentially reduce the burden of treatment. I am pleased that Argens has continued to expand the use of Halozyme’s proven Enfanze technology to support the patient’s independence and convenience. “

VYVGART approval® HYTRULO PREFILLED SYRINGE for self -injection is supported by data of research that assesses biological equivalence for Vyvgart.® Hite rule of the vial. In addition, human element verification studies have shown that participants with GMG or CIDP or caregivers are preparing and managing VYVGART safely and successfully.® Pre -filled syringes and height rules. VYVGART’s previous FDA approval® Hite Rulo in GMG and CIDP patients is based on global phase 3 adapt, adapt-SC and attachment tests.

About Halo

Halozyme is a biopharmaceutical company that develops destructive solutions to improve patients’ experiences and results for emerging and established therapy. As an innovator of ENHANZE® Drug delivery technology using monopoly enzyme RHUPH20, commercially proven solution of Halozyme is used to promote the subcutaneous delivery of the injected drugs and fluids with the goal of improving the patient’s experience with rapid subcutaneous delivery and reduced treatment burden. Halozyme licensed Enhanze after touching a million patients in marketing in more than 100 commercial products in more than 100 global markets.® ROCHE, TAKEDA, PFIZER, JANSSEN, ABBVIE, Eli Lilly, Bristol-Myers Squibb, Argenx, Viiv Healthcare, Chugai Pharmaceutical and Acumen Pharmaceutical Technology of Pharm and Biotechnology Company.

Halozyme is also manufactured, manufactured and commercialized with its own or partners using advanced automatic injection technology designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, comfort and compliance of improved patients. The company has two commercial products, Hylenex.® And xyosted®Commercial products and continuous product development programs with teva pharmaceuticals and Idorsia pharmaceuticals.

Halogaid is in the head office San Diego, California And there is an office Ewing, NJ and Minnetonka, Mn. Minnetonka It is also a site of the operating facility.

Please visit more details www.halozyme.com And connect with us from LinkedIn and Twitter.

Safe port statement

In addition to historical information, the statement mentioned above includes future prediction statements, including possible activities, benefits, and statements about enhanze.®Enlanze possible method®Potential applications to help distribute and absorption of other injection drugs and statements on other potential advantages of enhanze® Including the faster delivery of the drugs that can be injectable through subcutaneous delivery, the potentially lowering the treatment burden of the patient, it is possible to provide self -management and to enlarge the treatment options for the indications mentioned in this press release, thereby providing the flexibility to receive treatment in a more convenient position. This future prediction statement includes risks and uncertainty that actually different results can be different from future -oriented statements. Future prediction statements are generally not always identified using “expectation”, “faith”, “activation”, “possible”, “May”, “Will”, “Intention”, “Prediction”, “Plan”, “Prediction”, “Possible”, “Possible”, “Possible”, “Possible”, “Possible”, “Possible”, “Possible”, and similar meanings. The actual results may be substantially different from the expectations of the future predictions as a result of some factors, including unexpected results, delaying the release or commercialization of partner products mentioned in this press release, unexpected side effects, or patient experiences, or effects.® Co -formation treatment and competition conditions mentioned in this press release. These factors, which can lead to differences, are described in detail in Halozyme’s most recent annual and quarterly report submitted to the Securities and Exchange Commission. Except for the case required by the law, Halozyme is not obliged to update the future prediction statement to reflect the case after the release date.

contact lens:

tram
Vice President, Investor Relations and Corporate Communication
609-333-7668
tbui@halozyme.com

Samanda Gaspa
Hold on
212-886-9356
samantha.gaspar@teneo.com

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Source Haloja Treatment, Inc.



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