New Phase 2 Data Demonstrate Potential Benefit Of Nipocalimab For Pregnant Individuals At High Risk Of Early-Onset Severe Haemolytic Disease Of The Foetus And Newborn
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Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, announced positive results from the Phase 2 UNITY clinical trial for nipocalimab, a treatment for pregnant individuals at high risk of early-onset severe haemolytic disease of the foetus and newborn (HDFN). Nipocalimab is the only therapy in clinical development for this condition and has received orphan medicinal product designation from the European Medicines Agency and Fast Track designation from the U.S. Food and Drug Administration.
June 26, 2023 | 1:27 pm
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Johnson & Johnson subsidiary Janssen Pharmaceutical announced positive Phase 2 results for nipocalimab, a treatment for high-risk pregnancies affected by HDFN. The drug has received regulatory designations from the EMA and FDA.
The positive Phase 2 results for nipocalimab indicate that the drug has potential to address a serious and rare condition, which could lead to increased demand and revenue for Johnson & Johnson. The regulatory designations from the EMA and FDA further support the drug's potential and may expedite its approval process.
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