GMG

UCB announces U.S. availability of RYSTIGGO® (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Retrieved on: 
Friday, July 21, 2023

ATLANTA, July 21, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that RYSTIGGO is commercially available for the treatment of adult patients in the U.S. with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR)  or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Key Points: 
  • ATLANTA, July 21, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that RYSTIGGO is commercially available for the treatment of adult patients in the U.S. with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR)  or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
  • RYSTIGGO was approved under Priority Review by the U.S. Food and Drug Administration (FDA) on June 26, 2023.2
    RYSTIGGO is an HCP-administered injection, for subcutaneous use.
  • UCB also offers the "UCB Infusion Finder", an online search tool providing a non-exhaustive listing of approximately 1,000 infusion locations nationwide.
  • RYSTIGGO will have options for infusion at multiple sites of care, including physicians' offices, hospital outpatient clinics, and independent infusion centers.

BioCareSD Builds Depth as Limited Specialty Distributor by Adding ROCTAVIAN™, RYSTIGGO®, VYVGART® HYTRULO to Portfolio

Retrieved on: 
Tuesday, July 11, 2023

TEMPE, Ariz., July 11, 2023 /PRNewswire/ -- BioCareSD is excited to announce the addition of ROCTAVIAN™, RYSTIGGO®, and VYVGART® HYTRULO to their rapidly growing portfolio of life-saving specialty therapies.

Key Points: 
  • TEMPE, Ariz., July 11, 2023 /PRNewswire/ -- BioCareSD is excited to announce the addition of ROCTAVIAN™, RYSTIGGO®, and VYVGART® HYTRULO to their rapidly growing portfolio of life-saving specialty therapies.
  • BioCareSD is part of a limited distribution network for each therapy.
  • BioCareSD announces three new FDA-approved products to growing portfolio of life-saving specialty therapies.
  • VYVGART® HYTRULO is for subcutaneous use only and administered with a winged infusion set by a healthcare professional.

Zai Lab Announces Acceptance by China’s NMPA of the BLA for Efgartigimod Alfa Injection (Subcutaneous Injection) for Patients with Generalized Myasthenia Gravis

Retrieved on: 
Monday, July 10, 2023

SHANGHAI, China and CAMBRIDGE, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG).
  • “We are pleased to have the NMPA’s acceptance of the BLA for efgartigimod alfa injection for subcutaneous use.
  • Patients treated with efgartigimod SC achieved mean total IgG reduction of 66.4% from baseline at day 29, compared to 62.2% reduction with efgartigimod IV.
  • It was generally well-tolerated; the most frequent adverse event being injection site reactions (ISRs), commonly observed with biologics administered subcutaneously.

Zai Lab and argenx Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China

Retrieved on: 
Friday, June 30, 2023

SHANGHAI, China and CAMBRIDGE, Mass., June 30, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for VYVGART® (efgartigimod alfa injection), a first-in-class neonatal Fc receptor (FcRn) antagonist, as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. Zai Lab will now work with the National Healthcare Security Administration (NHSA) for NRDL inclusion to enable broad access for patients.

Key Points: 
  • Zai Lab will now work with the National Healthcare Security Administration (NHSA) for NRDL inclusion to enable broad access for patients.
  • “We are pleased to have the NMPA’s approval for VYVGART for intravenous use.
  • “We appreciate the NMPA for their thorough assessment of VYVGART, recognizing its differentiated profile and the large unmet medical need in China.
  • “We celebrate this achievement with our partner, Zai Lab, who shares our mutual passion to bring needed innovation to people with gMG in China.

argenx and Zai Lab Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China

Retrieved on: 
Friday, June 30, 2023

Amsterdam, the Netherlands— June 30, 2023 -- argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for VYVGART® (efgartigimod alfa injection), a first-in-class neonatal Fc receptor (FcRn) antagonist, as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. Zai Lab will now work with the National Healthcare Security Administration (NHSA) for NRDL inclusion to enable broad access for patients.

Key Points: 
  • Zai Lab will now work with the National Healthcare Security Administration (NHSA) for NRDL inclusion to enable broad access for patients.
  • ​​​“This approval by the NMPA for VYVGART, our sixth approval globally, is the first-and-only FcRn blocker available for people living with gMG in China.
  • “We celebrate this achievement with our partner, Zai Lab, who shares our mutual passion to bring needed innovation to people with gMG in China.
  • “We appreciate the NMPA for their thorough assessment of VYVGART, recognizing its differentiated profile and the large unmet medical need in China.

Harbour BioMed Announces Biologics License Application Acceptance of Batoclimab for Treatment of Generalized Myasthenia Gravis by NMPA

Retrieved on: 
Thursday, June 29, 2023

This is the first BLA accepted by NMPA since Harbour BioMed's establishment.

Key Points: 
  • This is the first BLA accepted by NMPA since Harbour BioMed's establishment.
  • "Anti-FcRn treatment is at the center of focus in gMG disease area.
  • Batoclimab is the first anti-FcRn treatment completed clinical development with positive results and confirmed efficacious and safe in Chinese gMG population.
  • "We are delighted that batoclimab has become our first BLA successfully accepted by the NMPA demonstrating our strong R&D capability.

Muscular Dystrophy Association Celebrates FDA Approval of UCB’s RYSTIGGO for the Treatment of Generalized Myasthenia Gravis

Retrieved on: 
Tuesday, June 27, 2023

New York, June 27, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of RYSTIGGO (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Key Points: 
  • New York, June 27, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of RYSTIGGO (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
  • RYSTIGGO is the only FDA-approved treatment in adults for both anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG, and will be administered as an injection for subcutaneous infusion.
  • Although treatment with RYSTIGGO will not cure gMG, it could lead to functional improvements that improve the daily life of individuals with gMG.
  • “Rystiggo is a welcome addition to the targeted therapeutic options available for the treatment of generalized myasthenia gravis,” said Sharon Hesterlee, Ph.D., Chief Research Officer, MDA.

Gabriel Marketing Group Wins Two Industry Awards for Excellence in Content Marketing

Retrieved on: 
Tuesday, June 27, 2023

MCLEAN, Va., June 27, 2023 /PRNewswire-PRWeb/ -- Gabriel Marketing Group (GMG), the industry's leading public relations and marketing agency for high-growth organizations, today announced its winning of a 2023 Hermes Creative Award and a 2023 Communicator Award for excellence in content marketing. Both awards recognized an ebook written and designed by GMG that presented the results of a national consumer survey commissioned by Kajeet, a provider of managed IoT solutions, to assess Americans' attitudes about access to high-speed internet access before the pandemic, during the pandemic and going forward.

Key Points: 
  • MCLEAN, Va., June 27, 2023 /PRNewswire-PRWeb/ -- Gabriel Marketing Group (GMG), the industry's leading public relations and marketing agency for high-growth organizations, today announced its winning of a 2023 Hermes Creative Award and a 2023 Communicator Award for excellence in content marketing.
  • GMG's two newest awards continue its winning streak of industry recognition for its growth marketing, content development and public relations work on behalf of clients.
  • They follow GMG's Ragan and PR Daily's 2023 Top Agencies Award, two 2023 AVA Digital Awards, five 2022 MarCom Awards and four 2022 dotCOMM Awards.
  • The Communicator Awards is an annual awards program that honors excellence in advertising, marketing, corporate communications and public relations.

UCB announces U.S. FDA approval of RYSTIGGO® (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis

Retrieved on: 
Tuesday, June 27, 2023

"There is a significant need for new, innovative treatment options to reduce the day-to-day burden of gMG.

Key Points: 
  • "There is a significant need for new, innovative treatment options to reduce the day-to-day burden of gMG.
  • RYSTIGGO ® is a new treatment option, targeting one of the mechanisms of disease to provide symptom improvement in patient-and physician reported outcomes at day 43."
  • The approval of RYSTIGGO® means doctors have an additional approved treatment option for their gMG patients who have not yet found a treatment that meets their needs."
  • RYSTIGGO® is also currently under review by the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with gMG.

Muscular Dystrophy Association Celebrates FDA Approval of argenx’s Vyvgart Hytrulo Injection for Treatment of Generalized Myasthenia Gravis

Retrieved on: 
Wednesday, June 21, 2023

New York, June 20, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of subcutaneous (SC) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc),for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Key Points: 
  • New York, June 20, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of subcutaneous (SC) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc),for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
  • Vyvgart Hytrulo is the first FDA-approved SC injectable for gMG and will be made available and marketed in the United States by argenx.
  • The new SC formulation can now be administered as a single injection (1,008 mg fixed dose) at home or in a physician’s office.
  • Although treatment with Vyvgart will not cure gMG, it could lead to functional improvements that improve the daily life of individuals with gMG.