Novartis Submits New Indication Application for Secukinumab Injection in China

On May 22, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) disclosed that Novartis had submitted a new indication application for its secukinumab injection (Cosentyx), with acceptance number JXSS1900025. The specific new indication applied for has not yet been disclosed.

Secukinumab Injection (Cosentyx, commonly known as “Su Jin Dan Kang”) has currently been launched in more than 80 countries and regions, including the United States and EU member states. It is supported by continuous efficacy and safety data from over 200,000 patients with up to five years of follow-up, and has been recommended for the treatment of psoriasis in multiple latest international guidelines, such as those in the United Kingdom, Germany, and Italy. Notably, the “2018 German S3 Guideline on the Treatment of Psoriasis Vulgaris” explicitly recommends this drug as a first-line therapy for moderate-to-severe psoriasis. The indications approved overseas for this drug include: plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

On April 1, 2019, Novartis Pharmaceuticals (China) announced that the National Medical Products Administration had approved Cosentyx for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. As the world’s first fully human interleukin-17A (IL-17A) inhibitor, this medication marks the first time a therapeutic agent has specifically targeted IL-17A, a key pathogenic factor. By selectively binding to and neutralizing IL-17A from multiple sources, it inhibits its pro-inflammatory effects and alleviates disease symptoms, thereby providing a rapid, durable, and safe treatment option for patients with moderate to severe psoriasis.

On May 20, Novartis Pharmaceuticals (China) announced once again that Cosentyx is now available at 58 hospitals across 28 cities in China.

Cosentyx officially submitted its marketing application in China in September 2018. It has been only eight months since it was introduced into clinical use, and merely 50 days elapsed from its market approval to formal clinical application. This demonstrates the Chinese government’s emphasis on accelerating the introduction of overseas new drugs. Notably, Cosentyx was included in the “First Batch of Overseas New Drugs Urgently Needed for Clinical Use,” released by the Center for Drug Evaluation of the National Medical Products Administration in 2018, as the first approved biologic agent for psoriasis.

It remains to be seen whether the new indication application for this drug will receive such rapid approval for market launch.

As early as March this year, Novartis announced the Phase III study data on the efficacy and safety of secukinumab in Chinese patients with moderate-to-severe plaque psoriasis. The Phase III study was a randomized, double-blind, placebo-controlled, international multicenter trial conducted over 52 weeks, enrolling a total of 543 patients, including 441 Chinese patients. The primary endpoints were the proportion of patients achieving PASI 75 (a 75% improvement in the Psoriasis Area and Severity Index) and IGA 2011 0/1 (an Investigator’s Global Assessment score of 0 or 1) at Week 12. The key secondary endpoint was the proportion of patients achieving PASI 90 (more than a 90% improvement in the Psoriasis Area and Severity Index) at Week 12. Enrolled patients were randomized into three groups to receive either Cosentyx 300 mg, Cosentyx 150 mg, or placebo, administered once every four weeks following the induction period.

Research results demonstrated that among Chinese patients treated with 300 mg of Cosentyx, symptoms were rapidly alleviated as early as Week 3. By Week 12, nearly 98% of patients achieved a PASI 75 response, and by Week 16, nearly 90% achieved a PASI 90 response. The principal investigator of the clinical trial acknowledged that the outcomes in terms of safety and efficacy were even superior to some international data, holding the promise of bringing transformative changes to the treatment of psoriasis in China.

Sources: Novartis official website, GBIHealth

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