IN BRIEF: J&J's Tecvayli recommended for indication extension by EMA

2 hours ago

(AWP Alliance News) - (AWP Alliance News) - Johnson & Johnson on Friday said the European Medicines Agency recommended the approval of an indication extension of Tecvayli for the treatment of adult patients with multiple myeloma.

The New Brunswick, New Jersey-based pharmaceutical company said the extension covers Tecvayli in combination with daratumumab for patients who have received at least one prior therapy.

"Unprecedented data show a meaningful extension in overall survival and minimal progression events observed after the first six months," said Ester Groen, EMEA Therapeutic Area Head of Haematology at Johnson & Johnson.

The Committee for Medicinal Products for Human Use at the EMA based its recommendation on data from the phase 3 MajesTEC-3 study, which showed an 83% reduction in the risk of disease progression or death in patients treated with Tecvayli plus daratumumab when compared to current standard of care.

"More than 90% of patients receiving the combination who were progression-free at six months remained progression-free at three years, highlighting the potential for durable long-term disease control," added Groen.

Separately on Friday, J&J presented new data on its Imaavy myasthenia gravis treatment at the European Academy of Neurology 2026 Congress, noting sustained disease control.

J&J presented data from its phase 3 Vivacity-MG3 study, demonstrating that Imaavy showed greater reductions in myasthenia gravis - Activities of Daily Living scores versus placebo plus standard-of-care at 24 weeks. The study also demonstrated that a greater proportion of patients receiving Imaavy also achieved sustained meaningful clinical improvement for over 20 weeks when compared to placebo.

The company also highlighted upcoming results from its Petunia study, which it said "is designed to generate real-world safety data on pregnancy, maternal, and infant outcomes following exposure to Imaavy during pregnancy."

Imaavy is currently approved for the treatment of generalized myasthenia gravis in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor or anti-muscle-specic tyrosine kinase antibody positive. The treatment is currently being investigated for other patient populations.

Shares in J&J traded up 3.7% at USD253.97 each in New York on Friday.

By John Robaina, Alliance News reporter

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