Novartis’ psoriasis blockbuster Cosentyx has beaten out rivals from Eli Lilly and Johnson & Johnson as the first interleukin inhibitor approved in China.
China’s National Medical Product Administration has approved Cosentyx to treat moderate-to-severe plaque psoriasis in adult patients, Novartis said Tuesday.
The nod comes months after the Center for Drug Evaluation put Cosentyx among 48 “clinically urgently needed drugs,” for which the agency invites their makers to file applications based on foreign data.
Novartis does have some China-specific data to back its case. In an ongoing phase 3 trial that includes 441 Chinese patients, Cosentyx achieved clear or almost clear skin—reaching a score of 90 on the Psoriasis Area Severity Index (PASI)—in 80.9% of patients during the first 12 weeks, and expanded the effect to 87% of patients after 16 weeks, according to data unveiled at the American Academy of Dermatology annual meeting in March. That trial will follow all 543 patients for a total of 52 weeks.
Cosentyx is the first IL-17A biologic approved in China, where an estimated 6 million people are living with psoriasis of varing levels of severity. But the drug’s competitors might not be so far behind. Eli Lilly’s Taltz, Johnson & Johnson’s Tremfya and Bausch Health’s Siliq (held by Kyowa Kirin in China) are also included in the Chinese CDE’s first batch of “clinically urgently needed drugs.”
The nod also comes just days after Novartis CEO Vas Narasimhan spoke at the annual China Development Forum in Beijing, where he shared the Swiss drugmaker’s high hopes for cell and gene therapies. In an interview with Bloomberg from last year at the 2018 version of the event, Narasimhan laid out an ambitious plan for Novartis in China that included aiming to more than double the company’s sales there over the next five years.
“We are seeing a material change now in China,” Narasimhan, who at that time had just taken over the CEO reins, told Bloomberg. “One of the things we are still looking for is faster reimbursement for higher-technology medicines.”
Despite its fast growth in the U.S., Cosentyx is facing some pressure from Tremfya, an IL-23 inhibitor. In a head-to-head phase 3 trial, the J&J drug posted a PASI 90 score in 84.5% of patients at Week 48, while only 70% Cosentyx patients reached that mark. But Novartis at that time played down the potential threat from the data, with Sam Khalil, Novartis’ head of worldwide medical affairs for immunology, hepatology and dermatology, predicting that it would “have limited clinical relevance.”
To strengthen its foothold in the world’s second-largest pharmaceutical market, and as a manifestation of Narasimahn’s emphasis on adoption of digital technologies, Novartis last year signed a partnership with Chinese internet tech giant Tencent, whose healthcare strategy also makes it a popular partner among multinational pharma companies. And just a few days ago, the pair expanded (Chinese) their collaboration to leverage Tencent’s artificial intelligence capabilities and social platform to help patients manage their chronic diseases such as heart failure.