Novartis is already racking up blockbuster sales in psoriasis with first-to-market IL-17 inhibitor Cosentyx, and could get another boost after claiming approval in China.
China’s National Medical Product Administration (NMPA) approved Cosentyx (secukinumab) for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
It’s the first drug in the IL-17 inhibitor class to be approved in China, ahead of Eli Lilly’s Taltz (ixekizumab) and Bausch Health’s Siliq (brodalumab), and also makes it the market ahead of other interleukin-targeting rivals including Johnson & Johnson’s Tremfya (guselkumab), which are also en route to market.
Approval means there is a new treatment option for patients at the more severe end of the psoriasis symptoms spectrum in China that can “act within three weeks, has demonstrated sustained safety in more than 200,000 patients worldwide and can deliver what doctors and patients are looking for,” said Paul Hudson, chief executive of Novartis’ pharma division.
Novartis says there are around six million people with psoriasis in China, but until now those with moderate-to-severe symptoms were limited to treatment with older systemic immunosuppressant drugs such as methotrexate, cyclosporine and acitretin, which have significant side effects.
The company has generated some specific clinical trial results in a Chinese patient population to support its regulatory filing there.
The ongoing CAIN457A2318 study is comparing Cosentyx with placebo in 543 patients with moderate-to-severe plaque psoriasis, including 441 Chinese patients. Preliminary results from the study showed that nine out of 10 patients who received Cosentyx achieved clear or almost clear skin after 16 weeks.
China is a growth target for Novartis, although the company has admitted it hasn’t quite kept pace with some other big pharma players there of late. Last year, CEO Vas Narasimhan said the aim is to more than double sales in China over the next five years, tapping into a Chinese regulatory overhaul that has made it quicker and easier to bring new drugs to market there.
The firm has recently picked up Chinese approvals for a clutch of therapies including Xolair (omalizumab) for asthma and heart failure therapy Entresto (valsartan/sacubitril).
Hudson said earlier this year that the company was “gathering some momentum and revisiting China [as] a real growth opportunity with what we have in market.”
Sales of Cosentyx were $2.8bn in 2018, up more than a third on 2017, but is expected to face competition from IL-23 inhibitor Tremfya, which is growing fast and made more than $540m last year. J&J is running a head-to-head trial of Tremfya versus Cosentyx in psoriasis to try to ramp up that pressure.