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Regeneron and Sanofi Provide Update on Ongoing Dupixent® (dupilumab) Chronic Spontaneous Urticaria Phase 3 Program
February 18, 2022 In this article:
| Analyst Report: Regeneron Phars, Inc TARRYTOWN, N.Y. and PARIS, Feb. 18, 2022 /PRNewswire/ --
In a Phase 3 trial in patients refractory to omalizumab, Dupixent did not reach statistical significance in interim analysis despite numeric improvements observed across key endpoints; trial will be stopped due to futility
Positive results from a previous Phase 3 trial in biologic-naïve patients showed Dupixent significantly reduced itch and hives compared to standard-of-care antihistamines alone
Companies remain committed to advancing Dupixent for patients with chronic spontaneous urticaria uncontrolled on antihistamines and are evaluating next steps
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced a Phase 3 trial (CUPID STUDY B) evaluating Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU) will stop due to futility, based on a pre-specified interim analysis. The trial, which assessed Dupixent added to antihistamines in patients refractory to omalizumab at 24 weeks, showed positive numerical trends in reducing itch and hives (the primary endpoints) but did not meet statistical significance during an interim analysis conducted by an independent review committee. The safety data were generally consistent with the known safety profile of Dupixent in its approved indications.
The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated direct-to-Phase 3 strategy. The previously reported Phase 3 trial, which evaluated a different group of patients who were biologic-naïve (i.e., not previously treated with omalizumab), met its primary and all key secondary endpoints at 24 weeks, showing that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone. The companies remain committed to advancing Dupixent for patients with CSU uncontrolled on antihistamines and are evaluating next steps.
Chronic spontaneous urticaria is a very complex disease, and these data add to the body of evidence assessing the underlying drivers of disease burden, including the potential role of interleukin-4 and interleukin-13, said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. While Dupixent did not show a significant benefit in the most difficult-to-treat patients who remain refractory to all approved medicines, we are carefully assessing the potential role of Dupixent in CSU based on the success of the first Phase 3 trial in biologic-naïve patients, where Dupixent nearly doubled the reduction in itch and urticaria activity.
Detailed results from the first trial will be presented at the AAAAI Annual Meeting later this month, and the companies expect to share results from the second trial in a scientific forum. Regeneron and Sanofi are rapidly advancing a broad clinical development program to evaluate Dupixent in diseases with significant unmet need and where type 2 inflammation may play a role. The companies also recently announced positive Phase 3 results in eosinophilic esophagitis (EoE) and prurigo nodularis (PN), and additional results are also expected later this year in pediatric EoE, chronic inducible urticaria-cold (CindU), and hand and foot atopic dermatitis.
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Regeneron¨î药¤½¥q¡]纳´µ达§J¡GREGN¡^©M赛诺µá¤½¥q¤µ¤Ñ«Å¥¬¡A®ÚÕu预¥ý«ü©wªº¤¤´Á¤ÀªR¡A评¦ôDupixent®¡]dupilumab¡^对ºC©Ê¦Û发©Ê荨³Â¯l¡]CSU¡^±wªÌªº3´Á试验¡]CUPID STUDY B¡^将¦]ÆӮĦӰ±¤î¡C该试验评¦ô¤F对奥马¯]单§Ü难ªvªº±wªÌ¦b24©P内将Dupixent²K¥[¨ì§Ü组Ói药ª«¤¤¡A¦bú£¤Öæ±Ö}©M荨³Â¯l¡]¥Dn终点¡^¤è±显¥Ü¥X积Ì媺数¦r趋势¡A¦ý¦b独¥ß审¬d©e员会进¦æªº¤¤´Á¤ÀªR¤¤没¦³达¨ì统计·Núå¡C¦w¥þ©Ê数ÕuÉODupixent¦b¨ä§å㪺Óì应¯g¤¤ªº¤wª¾¦w¥þ©Ê¯S©º°ò¥»¤@P¡C
LIBERTY-CUPID枢轴项¥Ø¤_2020¦~ûD动¡Aªö¨ú¤F¥[³tª½±µ进¤J3´Áªºµ¦²¤¡C¤§«e报¹Dªº3´Á试验评¦ô¤F¤£¦Pªº¥Íª«¨î剂ÆӮıwªÌ¸sÊ^¡]§Y¤§«e没¦³±µ¨ü过奥马¯]单§Üªv疗¡^¡A¦b24©P时达¨ì¤F¨ä¥Dn©M©Ò¦³关键ªº¦¸n终点¡Aªí©úÉO单独¨Ï¥Î§Ü组Ói药ª«¬Û¤ñ¡A¦b标ã护²z§Ü组Ói药ª«¤¤²K¥[Dupixent¥i显µÛú£¤Öæ±Ö}©M荨³Â¯l¡C两®a¤½¥q¤´µMP¤O¤_±À动Dupixent¥Î¤_¨Ï¥Î§Ü组Ói药ÆÓªk±±¨îªºCSU±wªÌ¡A¦}¥¿¦b评¦ô¤U¤@¨B¦æ动¡C
Regeneron¤½¥q总µôݺ®u¬ì学©xGeorge D. Yancopoulos³Õ¤h说¡GºC©Ê¦Û发©Ê荨³Â¯l¬O¤@Ïú«D±`Î`杂ªº¯e¯f¡A这¨Ç数Õu¼W¥[¤F评¦ô¯e¯f负ü®ýͦb驱动¦]¯Àªº证Õu¡A¥]¬A¥Õ细M¤¶¯À4©M¥Õ细M¤¶¯À13ªºýͦb§@¥Î¡C虽µMDupixent¦b对©Ò¦³获§å药ª«¤´难ªv¦nªº³Ì难ªv¦nªº¯f¤H¨¤W没¦³显¥Ü¥X©ú显ªº¦n处¡A¦ý§Ú们¥¿¦b¥J细评¦ôDupixent¦bCSU¤¤ªºýͦb§@¥Î¡A这¬O°ò¤_¦b¥Íª«¨î剂ÆӮĪº¯f¤H¨¤W进¦æªº²Ä¤@个3´Á试验ªº¦¨¥\¡ADupixent¨Ïæ±Ö}©M荨³Â¯l¬¡动ªºú£¤Ö¤L¥G½¤F¤@µf¡C
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March 29, 2022 1:11 PM GMT+8 Last Updated a day ago Sanofi targets Dupixent peak sales of over 13 billion euros Reuters
1 minute read Sanofi full-year results Sanofi logo at the company¡¦s headquarters during the annual results news conference in Paris, France, February 4, 2022. REUTERS/Benoit Tessier
Register now for FREE unlimited access to Reuters.com
PARIS, March 29 (Reuters) - French healthcare group Sanofi (SASY.PA), which lagged rivals in the race for COVID-19 vaccines, raised on Tuesday its peak sales target for eczema-treatment product Dupixent to more than 13 billion euros ($14.3 billion).
This new ambition does not include potential for additional sales ambition upgrade from chronic obstructive pulmonary disease (COPD), with pivotal readouts anticipated in 2023, Sanofi said in a statement.
This month, analysts at investment bank JP Morgan had said they expected Sanofi to raise its peak sales guidance for Dupixent to about $15 billion.
Sanofi is working with British partner GlaxoSmithKline (GSK.L) to develop a COVID-19 vaccine.
Sanofi also announced on Tuesday a partnership with U.S company IGM Biosciences in the field of treatments for oncology, immunology and inflammation.
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www.reuters.com/business/healthcare-pharmaceuticals/healthcare-group-sanofi-targets-dupixent-peak-sales-over-13-bln-euros-2022-03-29/
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