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Horizon Therapeutics has published new data from a long-term study of UPLIZNA, indicating a significant reduction in disease-related attacks for patients with anti-aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD) who received treatment for four or more years. Key findings include an annualized attack rate of 0.052 per patient year and a notable decline in attacks after the first year, with 92% of patients remaining attack-free in subsequent years. Additionally, the safety profile was consistent, with no new safety concerns reported.
Horizon Therapeutics (NASDAQ: HZNP) will present new analyses of UPLIZNA and NMOSD data at the 37th ECTRIMS Congress from October 13-15, 2021. UPLIZNA is the only FDA-approved anti-CD19 monoclonal antibody for treating adult patients with AQP4 antibody positive NMOSD. Key presentations include studies on B-cell depletion's impact on disease activity and long-term data on inebilizumab's safety and efficacy. A symposium titled 'Unraveling the Complexities of NMOSD' will be hosted on October 15.
Horizon Therapeutics announces the addition of five new development programs for investigational medicines Daxdilimab (HZN-7734) and Dazodalibep (HZN-4920), expanding its pipeline to a total of 27 programs. The new trials focus on conditions like alopecia areata, dermatomyositis, and lupus nephritis. With 10 data readouts expected by 2023, the company believes its robust pipeline may represent approximately $10 billion in peak annual net sales. The virtual R&D Day event marks a strategic step in Horizon's long-term growth trajectory.
Horizon Therapeutics plc (NASDAQ: HZNP) announced its virtual R&D Day for investors and analysts on Sept. 29, 2021, from 9 a.m. to 12:30 p.m. ET. The event will feature discussions on the company's expanded pipeline, including key topics such as Horizon’s vision and strategy and new drug candidates HZN-7734, HZN-4920, and HZN-825. R&D leadership and key opinion leaders will engage in Q&A sessions, highlighting the company’s commitment to addressing critical needs in rare and autoimmune diseases.
Horizon Therapeutics (Nasdaq: HZNP) has reported positive results from a retrospective analysis of African American participants in the Phase 2/3 N-MOmentum clinical trial for UPLIZNA, an anti-CD19 monoclonal antibody targeting NMOSD. Presenting at the 15th World Congress on Controversies in Neurology, data indicate UPLIZNA offers durable efficacy and a favorable safety profile. Key findings show a low annualized attack rate of 0.06 among treated patients and fewer infections compared to the placebo group. These insights can enhance treatment approaches for African Americans affected by NMOSD.
Horizon Therapeutics (Nasdaq: HZNP) has announced the winners of the Horizon Prize, ThinkGenetic Inc. and Congenica, who will receive $150,000 to enhance their solutions aimed at expediting rare disease diagnoses. ThinkGenetic utilizes algorithms to identify at-risk patients, while Congenica offers free diagnostic solutions to underrepresented groups. With rare disease patients facing an average diagnostic delay of nearly five years, this initiative aims to improve diagnosis speed and healthcare equity for approximately 400 million people worldwide.
HemoShear Therapeutics has received a milestone payment for advancing its gout treatment candidates in collaboration with Horizon Therapeutics (Nasdaq: HZNP). This payment is the fourth earned under their exclusive drug discovery agreement initiated in January 2019. The partnership combines Horizon's expertise in gout with HemoShear's REVEAL-Tx™ platform, potentially leading to over $500 million in future milestone payments and royalties. Gout affects over nine million people in the U.S., necessitating aggressive management to prevent severe pain and joint damage.
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Horizon Therapeutics announced the enrollment of the first patient in a Phase 4 clinical trial for TEPEZZA, aimed at treating chronic Thyroid Eye Disease (TED). TEPEZZA is the only FDA-approved treatment for TED, a serious autoimmune condition. The trial will assess the drug's efficacy, safety, and tolerability compared to a placebo, involving about 60 participants aged 18 or older. Primary endpoints include proptosis change at Week 24, along with other secondary effectiveness measures. The results may provide valuable insights into TEPEZZA's effectiveness in chronic TED cases.