VYVGART is the primary and solely FDA-approved neonatal Fc receptor blocker68% ofanti-acetylcholine receptor (AChR) antibody positivegMG sufferers handled with VYVGART have been responders (n=44/65) on the Myasthenia Gravis – Actions of Day by day Dwelling (MG-ADL) scale in contrast with 30% of sufferers handled with placebo (n=19/64) (p<0.0001) throughout the first remedy cycle within the Part 3 ADAPT trialZai Lab has unique rights to develop and commercialize efgartigimod in Better China and expects to file a New Drug Utility (NDA) in China by mid-2022
SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Dec. 17, 2021 (GLOBE NEWSWIRE) — Zai Lab Restricted (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, progressive, commercial-stage, world biopharmaceutical firm, at the moment introduced that its accomplice argenx SE (Euronext & Nasdaq: ARGX), a worldwide immunology firm dedicated to enhancing the lives of individuals affected by extreme autoimmune ailments and most cancers, at the moment introduced that the U.S. Meals and Drug Administration (FDA) has authorised VYVGART™ (efgartigimod alfa-fcab) for the remedy of generalized myasthenia gravis (gMG) in grownup sufferers who’re anti-acetylcholine receptor (AChR) antibody constructive. These sufferers characterize roughly 85% of the full gMG population1. With this regulatory milestone, VYVGART is the primary and solely FDA-approved neonatal Fc receptor (FcRn) blocker.
“Right this moment is the beginning of a brand new period for argenx and the gMG neighborhood as we honor our dedication to deliver ahead an progressive remedy possibility for individuals dwelling with this debilitating illness. The approval of VYVGART represents many achievements: our first authorised product; the primary and solely FDA-approved neonatal Fc receptor blocker; and the primary authorised remedy designed to scale back pathogenic IgGs, an underlying driver of gMG,” mentioned Tim Van Hauwermeiren, Chief Government Officer of argenx. “Importantly, we need to thank the sufferers, supportive caregivers, investigators and examine groups who participated within the ADAPT trial, in addition to our companions and devoted staff for his or her laborious work and collaboration – all of whom made this milestone attainable.
“Our extremely motivated industrial group is activated and able to ship VYVGART to sufferers. We consider the sector of autoimmunity is on the precipice of an evolution, and we hope that this would be the first of many VYVGART launches, permitting us to assist enhance the lives of sufferers around the globe,” continued Mr. Van Hauwermeiren.
“We congratulate our accomplice argenx for this primary approval,” mentioned Dr. Samantha Du, Founder, Chairperson and Chief Government Officer of Zai Lab. “With an estimated 200,000 sufferers dwelling with gMG in China, we see an ideal have to deliver efgartigimod to Chinese language sufferers with this autoimmune illness as expeditiously as attainable. We’ll work intently with the China Nationwide Medical Merchandise Administration (NMPA) to speed up entry for these sufferers with unmet medical wants. Efgartigimod has the potential to be the first-in-class FcRn remedy in China for gMG.”
Generalized myasthenia gravis is a uncommon and power neuromuscular illness characterised by debilitating and doubtlessly life-threatening muscle weak point. VYVGART is a human IgG1 antibody fragment that binds to FcRn, ensuing within the discount of circulating immunoglobulin G (IgG) antibodies. The motion of AChR autoantibodies on the neuromuscular junction is a key driver of gMG2.
Confirmed scientific efficacy and security profile
The approval of VYVGART is predicated on outcomes from the worldwide Part 3 ADAPT trial, which have been printed within the July 2021 situation of . The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL scale following treatment with VYVGART compared with placebo (68% vs. 30%; p<0.0001). Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle.
There were additionally significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with VYVGART compared with placebo (63% vs. 14%; p<0.0001). Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle.
VYVGART had a demonstrated safety profile in the ADAPT clinical trial. The most common adverse events in ADAPT were respiratory tract infection (33% vs 29% placebo), headache (32% vs 29% placebo), and urinary tract infection (10% vs. 5% placebo).
Marketing Authorization Applications for efgartigimod for the treatment of gMG are currently under review with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA), with anticipated decisions from each agency in the first quarter and second half of 2022, respectively.
See Important Safety Information and full Prescribing Information beneath for added data.
IMPORTANT SAFETY INFORMATION
What’s VYVGART™ (efgartigimod alfa-fcab)?
VYVGART is a prescription drugs used to deal with a situation referred to as generalized myasthenia gravis, which causes muscular tissues to tire and weaken simply all through the physique, in adults who’re constructive for antibodies directed towards a protein referred to as acetylcholine receptor (anti-AChR antibody constructive).
What’s a very powerful data I ought to learn about VYVGART?
VYVGART could trigger severe negative effects, together with:
An infection. VYVGART could enhance the chance of an infection. In a scientific examine, the most typical infections have 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. Nearly all of infections and blood negative effects have been gentle to reasonable 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 if in case you have any historical past of infections. Inform your well being care supplier straight away if in case 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 could cause the immune system to have undesirable reactions equivalent to rashes, swelling below the pores and skin, and shortness of breath. In scientific research, the reactions have been gentle or reasonable 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 your whole medical circumstances, together with if you happen to:
Have a historical past of an infection otherwise you suppose you might have an an infection Have obtained or are scheduled to obtain a vaccine (immunization). Focus on along with your well being care supplier whether or not it’s worthwhile to 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 security with dwell or live-attenuated vaccines is unknown. Administration of dwell or live-attenuated vaccines is just not advisable throughout remedy with VYVGART. Are pregnant or plan to change 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 most typical 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. It’s possible you’ll report negative effects to the US Meals and Drug Administration at 1-800-FDA-1088.
Please see the total Prescribing Info for VYVGART and discuss to your physician.
About Part 3 ADAPT Trial
The Part 3 ADAPT trial was a 26-week randomized, double-blind, placebo-controlled, multi-center, world trial evaluating the security and efficacy of VYVGART in grownup sufferers with gMG. A complete of 167 grownup sufferers with gMG in North America, Europe and Japan enrolled within the trial. Sufferers have been randomized in a 1:1 ratio to obtain VYVGART or placebo, along with secure doses of their present gMG remedy. ADAPT was designed to allow an individualized remedy method with an preliminary remedy cycle adopted by subsequent remedy cycles primarily based on scientific analysis. The first endpoint was the comparability of share of MG-ADL responders within the first remedy cycle between VYVGART and placebo remedy teams within the anti-AChR antibody constructive inhabitants.
About VYVGART
VYVGART (efgartigimod alfa-fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), ensuing within the discount of circulating IgG. It’s the first and solely authorised FcRn blocker. VYVGART is authorised in the USA for the remedy of adults with generalized myasthenia gravis (gMG) who’re anti-AChR antibody constructive.
About Generalized Myasthenia Gravis
Generalized myasthenia gravis (gMG) is a uncommon and power autoimmune illness the place IgG autoantibodies disrupt communication between nerves and muscular tissues, inflicting debilitating and doubtlessly life-threatening muscle weak point. Roughly 85% of individuals with MG progress to gMG inside 24 months1, the place muscular tissues all through the physique could also be affected. Sufferers with confirmed AChR antibodies account for about 85% of the full gMG population1.
About Zai Lab
Zai Lab Restricted (NASDAQ: ZLAB; HKEX: 9688) is a patient-focused, progressive, commercial-stage, world biopharmaceutical firm targeted on creating and commercializing therapies that handle medical circumstances with unmet wants in oncology, autoimmune problems, infectious ailments, and neuroscience. To that finish, our skilled group has secured partnerships with main world biopharmaceutical corporations in an effort to generate a broad pipeline of progressive marketed merchandise and product candidates. We’ve additionally constructed an in-house group with sturdy product discovery and translational analysis capabilities and are establishing a pipeline of proprietary product candidates with world rights. Our imaginative and prescient is to change into a number one world biopharmaceutical firm, discovering, creating, manufacturing, and commercializing our portfolio in an effort to affect human well being worldwide.
For extra details about the corporate, please go to www.zailaboratory.com or comply with us at www.twitter.com/ZaiLab—Global.
Zai Lab Ahead-Wanting Statements
This press launch incorporates statements about future expectations, plans and prospects for Zai Lab, together with, with out limitation, statements relating to the prospects of and plans for commercializing efgartigimod within the Better China area. These forward-looking statements could comprise phrases equivalent to “goal,” “anticipate,” “consider,” “might,” “estimate,” “anticipate,” “forecast,” “aim,” “intend,” “could,” “plan,” “attainable,” “potential,” “will,” “would” and different comparable expressions. Such statements represent forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995. Ahead-looking statements aren’t statements of historic truth, nor are they ensures or assurances of future efficiency. Ahead-looking statements are primarily based on our expectations and assumptions as of the date of this press launch and are topic to inherent uncertainties, dangers, and adjustments in circumstances that will differ materially from these contemplated by the forward-looking statements. Precise outcomes could differ materially from these indicated by such forward-looking statements on account of varied vital elements, together with however not restricted to (1) our skill to efficiently commercialize and generate income from our authorised merchandise, (2) our skill to finance our operations and enterprise initiatives and procure funding for such actions, (3) our outcomes of scientific and pre-clinical growth of our product candidates, (4) the content material and timing of selections made by the related regulatory authorities relating to regulatory approvals of our product candidates, (5) the results of the novel coronavirus (COVID-19) pandemic on our enterprise and common financial, regulatory, and political circumstances, and (6) the chance elements recognized in our most up-to-date annual or quarterly report and in different stories we’ve got filed with the U.S. Securities and Change Fee. We anticipate that subsequent occasions and developments will trigger our expectations and assumptions to vary, and we undertake no obligation to replace or revise any forward-looking statements, whether or not on account of new data, future occasions, or in any other case, besides as could also be required by regulation. These forward-looking statements shouldn’t be relied upon as representing our views as of any date subsequent to the date of this press launch.
For extra investor-related details about Zai Lab, please go to www.SEC.gov or go to www.zailaboratory.com.
References
1 Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277
2 Howard JF Jr, Utsugisawa Ok, Benatar M, et al. Security and efficacy of efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a section 3, randomised, double-blind, placebo-controlled, multicenter examine. Lancet Neurol. 2017; 16: 976-86
For extra data, please contact:
Investor Relations: Ron Aldridge / Lina Zhang +1 (781) 434-8465 / +86 136 8257 6943 ronald.aldridge@zailaboratory.com / lina.zhang@zailaboratory.com
Media: Danielle Halstrom / Xiaoyu Chen +1 (215) 280-3898 / +86 185 0015 5011 danielle.halstrom@zailaboratory.com / xiaoyu.chen@zailaboratory.com
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