J&J's nipocalimab fast-tracked for Sjogren's disease

Johnson & Johnson's FcRn inhibitor nipocalimab has been awarded fast-track status by the FDA as a treatment for Sjögren's disease (SjD), an autoimmune condition that affects millions of people worldwide, but has no treatments that address the underlying cause.

The new status adds to the earlier breakthrough designation for the drug and comes as J&J is waiting for the results of its first phase 3 trial in moderate-to-severe SjD – called DAFFODIL – which started in December.

Last year, J&J reported results from the phase 2 DAHLIAS trial, which showed improvements in various measures of SjD disease activity with nipocalimab compared to placebo.

SjD is characterised by the production of auto-antibodies, leading to chronic inflammation that leads to dryness in mucosal surfaces like the eyes and mouth and affects around 4 million people worldwide. It can also cause damage to organs, including the joints, lungs, kidneys, and nervous system, and raises the risk of B-cell lymphomas by 20 times, leading to an increased risk of early death.

Nipocalimab has been described by J&J as a "Swiss army knife" for autoimmune diseases, with a long list of potential indications that includes generalised myasthenia gravis (gMG), warm autoimmune haemolytic anaemia (wAIHA), and chronic inflammatory demyelinating polyneuropathy (CIDP), amongst others. It is also in mid-stage testing for more common disorders, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).

The company has previously suggested that the drug could become a $5 billion-a-year product, despite trailing behind other drugs in the FcRn inhibitor class – Argenx's Vyvgart (efgartigimod alfa) family and UCB's Rystiggo (rozanolixizumab) – which have already reached the market for gMG and are in clinical testing for various other indications.

Nipocalimab has been filed for gMG in the US and was awarded a priority review in January, setting up an FDA decision in the summer.

In a statement, J&J said that the drug is the first biologic to get breakthrough status from the FDA, which alongside the fast-track status should "accelerate the delivery" of the drug for SjD patients.

"This marks an additional important step forward in our efforts to bring meaningful advancements to people living with Sjögren's disease, a serious and debilitating condition," said Katie Abouzahr, head of J&J's autoantibody portfolio and maternal foetal disease area leader.

"We look forward to continuing to work closely with the FDA to advance the clinical development of nipocalimab and potentially provide a much-needed treatment option for this community."

Argenx also has SjD in its sights for Vyvgart and is currently running the phase 3 Unity trial, which also started last December and followed proof-of-concept data with its subcutaneously administered Vyvgart Hytrulo formulation of the drug.