Eli Lilly announced on Sep. 4 that its new psoriasis drug: ixekizumab (Taltz®) had entered China and passed the marketing approval of the NMPA, which is another blockbuster psoriasis drug approved following the approval of the "first-in-class" new drug benvitimod in preceding days in China. It is worth mentioning that benvitimod is a drug for external use and its some efficacy indicators are superior to the "golden standard" drug for external use in the current treatment of psoriasis. And ixekizumab is an injection for internal use. This means that the NMPA has been focusing on the interior and exterior in its recent approval of psoriasis drugs, which can be called a great change in the Chinese psoriasis drug market.

I’ve interpreted the "first-in-class" new psoriasis drug for external use: benvitimod in a previous article, which I will not detail again here.

Ixekizumab injection approved this time is a monoclonal antibody targeting the proinflammatory cytokine interleukin 17A (IL-17A), which can inhibit the binding of IL-17A to IL-17A receptor. It is the second anti-IL-17A monoclonal antibody approved by the FDA for marketing following Novartis’ blockbuster anti-inflammatory agent: Cosentyx (secukinumab). From the perspective of the global market, the industry is generally optimistic about ixekizumab injection, of which the global annual sales may exceed USD1 billion. According to the clinical study results (UNCOVER-2), after using ixekizumab injection, 40% of patients achieved PASI 100 (PASI=Psoriasis Area Severity Index) and 71% achieved PASI 90.

The NMPA of China included ixekizumab injection into the list of 48 clinically imperative new drugs marketed overseas in August last year because psoriasis is a chronic, recurrent, immune-mediated multisystem disease; moderate to severe psoriasis can lower the quality of life and even cause disability; traditional drugs (methotrexate (MTX), acitretin, ciclosporin, and other drugs) have different kinds of potential toxicity, while the product has been proved to possess good therapeutic effects and good tolerance in overseas studies; the product is an anti-IL-17 monoclonal antibody drug that has a high affinity and specificity to IL-17A; and there is no drug with such action of mechanism for psoriasis treatment for the moment in China. It only took 12 months for ixekizumab injection to be formally marketed in China, which is big good news to the more than 6 million psoriasis patients in China.

Targeted drugs of psoriasis have developed rapidly in recent years, which has brought great progress to psoriasis treatment. Such drugs can be roughly divided into the following categories according to the targeting mechanism:

1. IL receptor inhibitors: a) IL-17A receptor antagonists: ixekizumab and Novartis’ secukinumab (approved by the FDA for marketing in 2015); b) IL-12/IL-23 antagonists, such as ustekinumab (the first IL-12/IL-23 antagonist approved by the U.S. FDA to treat moderate to severe plaque psoriasis) and guselkumab (approved by the FDA for marketing in 2017);

2. Tumor necrosis factor-α (TNF-α) inhibitors: TNF-α has been a key target in psoriasis and psoriatic arthritis treatment in recent years; by July 2018, TNF-α inhibitors marketed in China and overseas included infliximab, etanercept, adalimumab, and golimumab, and the one marketed overseas but still at the clinical trial stage in China is certolizumab;

3. Phosphodiesterase-4 (PDE-4) inhibitors: such as the marketed oral drug: apremilast;

4. T-cell-targeted drugs: such as alefacept and itolizumab;

5. Cell signaling small molecule inhibitors: a) JAK inhibitors, such as tofacitinib and baricitinib; b) PKC inhibitors, such as sotrastaurin; c) Sphingosine-1-phosphate receptor 1 (S1PR1)-targeted preparations, such as Ponesimod; d) Mitogen-activated protein/extracellular signal-regulated kinase (MEK) inhibitors, such as E6201;

6. Vascular endothelial growth factor (VEGF) inhibitors, such as monoclonal antibody G6-31, fusion protein Valpha, and tyrosine kinase inhibitor NVP- BAW2881.

Psoriasis can cause chronic joint damage and even cause disability or death of patients and has become a major public health problem in the world. The approval of new drugs brings new choices to Chinese patients. Ixekizumab’s approval is another great news to Chinese psoriasis patients following the approval of benvitimod and both can complement each other.

References:

1. Official website of Eli Lilly;

2. Official website of CDE, Notice on Soliciting Opinions on the List of Clinically Imperative New Drugs that are Marketed Overseas:
http://www.cde.org.cn/news.do?method=largeInfo&id=314651;

3. Progress of Research on Targeted Drugs for Psoriasis, China Pharmacy, 2019.

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