One Year Post-Launch of Argenx's Vyvgart for gMG, US Neurologists Confused on Best Approach to Treatment Dosing Schedules, According to Spherix Global Insights

Vyvgart was initially well received by half of the neurologists and neuromuscular specialists surveyed. However, they are still uncertain about re-dosing following the second treatment cycle.

EXTON (Pa.), February 24, 2023 /PRNewswire/ - Vyvgart (efgartigimod), Argenx's global launch, has been a huge success with a first-year revenue exceeding $400million USD. Vyvgart is the second biologic to be approved for generalized myasthenia Gravis (gMG) as well as the first neonatal FcRn (FcRn-blocker) inhibitor. This unique and targeted mechanism of action has been well received by HCPs. Spherix Global Insights surveyed neurologists and neuromuscular experts to find Vyvgart addresses a significant unmet need in the treatment for this rare, chronic autoimmune condition.

Although argenx's brand is well-received, the majority of respondents (n=69), are less positive about Vyvgart’s dosing profile. Its infusion administration is similar to other approved biologics for the gMG, Alexion's Soliris or Ultomiris. However, unlike these brands it allows for some flexibility in dosing. According to the label and data from Phase 3 ADAPT trial, Vyvgart is administered in four (4) infusions spaced one week apart. Then, a treatment-free period is followed by additional cycles as required based on clinical evaluation.

It is interesting that half of the respondents still have uncertainty about when to re-dose patients following a Vyvgart treatment. Unaided, Vyvgart's greatest disadvantages were identified by two fifths of respondents. Respondents reported:

"Re-treatment time will be determined if symptoms reappear, and requires a subjective report from patient."

"I sometimes get pushback on the frequency of my infusions. I'm not always certain when the next infusion should take place.

"Uncertainty about how to dose after the first round."

"Expensive, frequent infusions make it difficult to know when to re-dose.

The findings were further confirmed by qualitative interviews with Vyvgart prescribers. One neurologist recalled mixed feelings about Vyvgart’s flexible dosing.

"The hassle with Vyvgart I mean, now we're gaining expertise, but the flexibility to dosing may prove to be a good or a poor thing. It is what it is. It is possible that I will have different feelings over time. It may be something I like, or it may make me mad.

The next question, when viewed in context, is whether future launches could capitalize upon questions around Vyvgart flexibility dosing. These questions are likely to linger with argenx's expected approval of subcutaneous efgartigimod by June 2023. It will most likely have similar flexible doses.

UCB's rozanolixizumab, a FcRn blocking drug, is the first to be launched. It will also receive a PDUFA in Q2 2023. Janssen's nipocalimab could also be launched in this class. Other contenders to argenx's FcRn blocker franchise include Genentech’s Enspryng, (satralizumab), and Horizon's Uplinza, (inebilizumab), which have both been approved by NMOSD and are currently in the late-phase of development for gMG. The early views of neurologists on the pipeline reveal that Enspryng (satralizumab) and Uplinza have already attracted high interest. This is mainly due to their distinct dosing frequencies and mechanisms of action and potential efficacy.

Spherix will monitor the evolution of the US gMG market with multiple services in 2023. Spherix' Launch LINK service will monitor the impact of the brands on the US gMG markets, including the anticipated launches of subcutaneous Efgartigimod (rozanolixizumab) and rozanolixizumab. Through research with general neurologists as well as specialists in the Market LINK program, insight on the inline and pipeline assets as well as the remaining unmet needs of gMG will be gathered in the US and EU. RealWorld LINK will be the first service to explore the gMG patient experience, including line and therapy, brand drivers, next switches, and potential patient profiles for new therapies.

Spherix's 2023 GMG Publication Plan: Click Here to View the 2023 GMG Publication plan.

About Launch LINK

Launch _LINK is an independent service that provides monthly benchmarking for newly launched products during the first 18 months of commercial availability. It also includes a quarterly deep dive into promotional activity and barriers to uptake.

About Market LINK

Market LINK provides independent analysis of markets that will experience a paradigm shift in the next three to five year. Market insights highlight market size, treatment options, unmet need, and expert opinions about the disruption likely to be caused by pipeline agents.

RealWorld LINK

RealWorld LINK, an independent data-driven service, reveals real patient management patterns through the rigorous analysis of large patient chart audits. Insights provide insight into the "why" behind treatment decisions. This includes year-over-year trending to quantify key market aspects and integrate demographic and specialist data to highlight differences in treatment patterns.

About Spherix Global Insights

Spherix Global Insights, a leader in market research, business intelligence, and advisory services for the global life science industry is Spherix Global Insights. Spherix Network's specialty physicians and unique analysis to support strategic decision-making by valued customers are the key ingredients of the company's unique service offerings.

Spherix Global Insights is a trusted advisor and thought leader in the industry. They provide specialized market knowledge in six (6) targeted therapeutic areas, including dermatology, gastroenterology and neurology.

To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter.

Spherix Global Insights Contacts

Emma McFadden, Senior Insights Director, EMAIL

Scott Upham, Corporate EMAIL

NOTE: All company, brand and product names used in this press release are trademarked by their respective owners. These opinions and findings are based upon Spherix Global Insight analysis. They do not indicate any endorsement or relationship with any company, brand or product.

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