J&J Seeks FDA Approval for Nipocalimab in Myasthenia Gravis Market Battle

Johnson & Johnson (J&J) has officially filed for FDA approval of nipocalimab, an FcRn blocker acquired in its $6.5 billion takeover of Momenta Pharmaceuticals in 2020. This move positions J&J against Argenx's Vyvgart and UCB's Rystiggo in the competitive generalized myasthenia gravis (gMG) market. Despite entering after its rivals, J&J believes nipocalimab could surpass $5 billion in peak sales by offering distinct advantages, such as sustained disease control when used alongside standard care.

J&J's strategy for nipocalimab hinges on its unique clinical data, which the company argues sets it apart from competitors in the gMG space. Specifically, J&J highlights nipocalimab’s ability to maintain disease control over six months, a key differentiator in their pitch. Although Vyvgart and Rystiggo already serve most gMG patients, J&J aims to broaden its market by enrolling a wider patient population in its studies, positioning nipocalimab as a versatile treatment option.

The battle among J&J, Argenx, and UCB is likely to extend across multiple indications as each company seeks to dominate the FcRn blocker market. While Argenx capitalizes on its first-mover advantage, UCB and J&J are strategizing to carve out their own market niches. The competitive landscape is expected to intensify as these companies strive for leadership in gMG and other autoimmune disorders.

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