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银屑病治疗终极PK :诺华Cosentyx完胜强生Stelara

2015-03-17 13:29:16 来源:生物谷

2015年3月16日 讯/生物谷BIOON/--诺华于昨日宣布,后期临床试验结果表明其治疗银屑病的新药Cosentyx优于强生公司的拳头产品Stelara。

Cosentyx目前在治疗银屑病的新药IL-17阻断剂类产品中占据领先地位。IL-17是一种促炎性因子,在银屑病侵染的身体部位高浓度累积,这类阻断剂可以特异性阻断IL-17。强生的Stelara属于IL-12和IL-23抑制剂类药物,去年该药销售额达到13亿美金。

一项称为CLEAR的早期临床试验已经表明,在接受16周的治疗后,Cosentyx比Stelara能更有效地清除皮肤上的银屑斑块。另一项称为FIXTURE和ERASURE的研究表明,Cosentyx与它的竞争药物相比是一个更好的选择,因为它更容易实现完全清除或大部分清除。

该研究比较了诺华的Cosentyx、强生的Stelara、以及安进的生物疗法Enbrel。来自FIXTURE的试验结果表明,在这个时间点72%使用Cosentyx的患者皮肤银屑斑块得到明显清除,而使用Enbrel的患者仅有31%。同样,与Stelara相比结果也类似。诺华已经计划在本月末举办的美国皮肤病学术会议中报告这些研究结果。Cosentyx是首个在临床试验中能达到90%斑块清除的药物,被称为能给患者提供明显缓解的最佳药物。

全球大约有1.25亿银屑病患者。诺华预计欧洲大约有370万人患有此病,其中有240万患者属于中到重度。另一个与银屑病密切相关的是银屑病关节炎,患者的关节遭受疾病侵犯。大约40%的患者最终将发展为生理残疾或者永久性的关节损害。

2014年12月26日,Cosentyx在日本首先获批,用于治疗银屑病和银屑病关节炎。今年1月19日,该药物在欧洲批准上市。随后,美国FDA批准了该药物作为治疗成年人中到重度银屑病的一线药物。

诺华也评估了Cosentyx在治疗强制性脊柱炎方面的疗效。公司预计将于今年晚些时候提交该药物扩展预期用途的申请。

生物谷推荐英文原文报道:

Novartis AG (ADR) Cosentyx More Effective Than Johnson & Johnson Stelara

Novartis AG (ADR) (NYSE:NVS) announced yesterday that results from a late-stage clinical trial demonstrated that Cosentyx, its new treatment for psoriasis, outperformed Johnson & Johnson’s (NYSE:JNJ) blockbuster drug Stelara.

Cosentyx (secukinumab) is currently the leader among the new class of psoriasis treatments known as interlukin-17 (IL-17) inhibitors. The said class of inhibitors works by blocking IL-17, a pro-inflammatory protein which is found in concentrated levels on psoriasis-affected areas of the body. J&J’s Stelara belongs to the IL-12 and IL-23 inhibitor class of treatments. The said drug generated $1.3 billion in sales last year.

Data results from an earlier trial called CLEAR had already established that Cosentyx cleared psoriasis lesions more effectively than Stelara after a 16-week treatment. Results from new extended studies – FIXTURE and ERASURE – established that Cosentyx was still a better option, achieving “clear or almost clear skin” than its competitors.

The studies compared Cosentyx to Stelara and Amgen, Inc.’s (NASDAQ:AMGN) biologic therapy Enbrel.

The results from FIXTURE demonstrated that “72% of patients had clear skin at this timepoint with Cosentyx compared to just 31% of the Enbrel group.” Similarly, the drug showed same results when compared with Stelara, Novartis reported. Novartis has plans to present the results from these studies at the American Academy of Dermatology meeting which is scheduled to be held later this month.

Cosentyx is the first ever drug to achieve 90% clearance of lesions (known as a PASI 90 score) in a clinical trial to 100% clearance (PASI 100). The said outcomes are known as “optimal responses” for drug treatments which provide significant relief to patients.

Psoriasis is a chronic condition characterized by extensive thick lesions and plaques on skin which results in severe itching, aches, and scaling. The condition has severe effects on psychological and physical aspects of patients as well.

Approximately 125 million people around the world have been estimated to be affected by psoriasis.

According to the estimates presented by Novartis, as many as 3.7 million people suffer from the skin condition in Europe alone; out of this massive number, 2.4 million individuals experience moderate-to-severe conditions of the disease.

Another condition closely related to psoriasis is psoriatic arthritis, which damages the joints of affected patients. Approximately 40% of the patients suffering from psoriatic arthritis ultimately develop physical deformity or suffer from permanent destruction of joints.

December 26, 2014 marked the first approval for an IL-17 inhibitor, as Japanese regulators approved Cosentyx to be marketed and used as a treatment for psoriasis and active psoriatic arthritis. The drug won the European approval on January 19 this year. The US Food and Drug Administration’s approval followed next, as the agency gave a green signal for the drug to be used as a first-line systematic treatment for moderate-to-severe plaque psoriasis in adults.

Novartis is currently the leader in IL-17 inhibitors market, as other pharmaceutical giants race to secure their positions as well. AstraZeneca Plc (ADR) (NYSE:AZN) and Amgen together are developing an IL-17 inhibitor, brodalumab, which is currently in its late-stage clinical evaluation trial. Eli Lilly & Co.’s (NYSE:LLY) IL-17 inhibitor, ixekizumab, is also in its Phase III clinical trial.

Novartis is also evaluating Cosentyx for the treatment of ankylosing spondylitis, a type of spine arthritis. The company is expected to file an application to get approval for the extended use of the drug to treat the condition later this year.

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