Generalized Myasthenia Gravis Pipeline Assessment Unveils Top Contenders to Challenge Current Market Biologics - New Spherix Report

High interest in argenx's SC efgartigimod, Sanofi's tolebrutinib, Genentech's satralizumab, and Horizon's inebilizumab

EXTON, Pa., Oct. 6, 2022 /PRNewswire/ -- The recent launches of argenx's Vyvgart and Alexion's Ultomiris for the treatment of generalized myasthenia gravis (gMG), a debilitating and chronic autoimmune neuromuscular disorder, have provided patients with a new mechanism of action and new dosing options to tackle their disease. With at least five pipeline assets poised to gain FDA approval within the next two years, the competition is only expected to intensify.

Spherix surveyed 98 neurologists who prescribe biologics to their gMG patients in order to assess the current treatment and pipeline landscape. The 2022 Market Dynamix™ study found that respondents emphasize the importance of the safety profile and disease-modifying effect when selecting a therapy for gMG treatment. At present, prescribers reportedly reserve the approved biologics (which also includes Alexion's Soliris) as later-line options for patients with at least moderate disease severity.

However, neurologists note that the availability of novel mechanisms of action has changed their treatment approach in gMG and unaided anticipate increased use of new biologics over the next year. Respondents also indicate a preference for treating gMG patients as early and aggressively as possible, suggesting that biologics may advance to earlier lines of therapy over time.

Among nine profiled late-phase therapies in development for gMG, neurologists' level of interest in having these agents approved and available was relatively even across all options. However, four assets slightly stood out among the crowd – Genentech's subcutaneous (SC) anti-IL-6 monoclonal antibody (mAb), satralizumab, argenx's SC FcRn blocker, efgartigimod, Sanofi's oral BTK inhibitor, tolebrutinib, and Horizon's anti-CD19 mAb, inebilizumab.

Of note, at least one-third of respondents also considered UCB's FcRn-binding antibody, rozanolixizumab to be one of their top three most desired emerging agents to gain approval – falling shortly behind the front runners.

In fact, rozanolixizumab's efficacy, including among anti-MuSK-antibody positive patients, was reported (unaided) as one of the agent's biggest advantages. With higher perceived levels of unmet need among anti-AChR antibody negative patients, demonstrated efficacy among these smaller populations could serve as points of differentiation for a market that is expected to become increasingly crowded.

Alternative modes of delivery could also serve to distinguish between brands in a biologic market currently dominated by intravenous options, offering a potential foothold for emerging agents that can offer at-home administration. As one interviewed neurologist noted, "I think subcutaneous is going to be a game changer because that is way easer to administer."

Indeed, many neurologists agree that their gMG patients benefit from having access to multiple FcRn-directed therapies and C5-targeted therapies, suggesting room for multiple options even within the same drug class, with delivery a potential key differentiator.

Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years, highlighting market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.

Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology, and ophthalmology market.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Emma McFadden, Senior Insights Director, Neurology
Email: [email protected]
www.spherixglobalinsights.com

SOURCE Spherix Global Insights