Filgtotinib - multiple potential indications are expected to drive sales up

In February 2020, Corellis drug to watch released the annual report of 2020 Corellis drug to watch, which predicted that 11 new drugs (heavyweight drugs) will be launched in 2020 and the annual sales volume is expected to exceed 1 billion US dollars by 2024 According to the data analysis of cortellis drugs to watch, filgotinib (glpg-0634) has the potential to become a blockbuster drug, and it is expected to reach the desired annual sales volume of 1 billion USD after a series of indications are approved Filgoinib is an oral small molecule inhibitor of Janus kinase 1 (Jak1); over activation / imbalance of Jak1 can lead to autoimmune response Currently, filgotinib, which is used to treat rheumatoid arthritis, has applied for listing in the European Union in August 2019, Japan in October 2019 and the United States in December 2019, and has entered the review stage To ensure that the drug can be approved by FDA quickly, Gilead Sciences Inc has used a priority review voucher, which will shorten the review time by four months As a partner of Geely, Galapagos NV and Weicai will sell filgotinib in many regions around the world to enter the crowded rheumatoid arthritis market In addition to non steroidal anti-inflammatory drugs, steroids and anti rheumatic drugs (DMARDs) such as methotrexate have generic drugs There are many drugs in this red sea that aim at different mechanisms of action, including TNF - α inhibitors, Albright's global sales champion, adalimumab, and orencia, a T-cell co stimulation regulator of Bristol Myers Squibb (abatacept, abatacept); kineret (anakinra), an interleukin-1 antagonist of SOBI Inc., and kevzara (sarilumab), an antibody against IL-6 of metapharma and Sanofi, Actemra of Roche, rituximab of Bojian and Roche, and several JAK inhibitors, including xeljanz of Pfizer, olumiant of Lilly and rinvoq of Aberdeen "Obviously, we are very clear about how competitive this is There is no doubt about it." Johanna Mercier, Geely's chief business officer, said in a conference call in the fourth quarter of 2019 Although many drugs have been approved for the treatment of rheumatoid arthritis, patients still hope to have more options "The problem is not solved yet," Ms Kelly O'Neill, chairman and founder of the rheumatoid patient foundation, told BioWorld O'Neill currently runs the RA warrior website and has written a book about the disease "Once the new treatment is slightly different from the existing one, I would recommend approval," she said O'Neill was diagnosed with rheumatoid arthritis in 2006, after more than 20 years of suffering from a growing disease She is currently on treatment for a second JAK kinase inhibitor She stressed that about one-third of the patients did not respond significantly to the current treatment, another third only responded partially, the rest were sensitive to drugs, but the efficacy would gradually weaken over time Filgtotinib was launched based on the results of a series of phase III clinical studies called finch In the finch 1 study, filgitinib was used in combination with methotrexate for 12 weeks in patients who did not respond adequately to methotrexate alone The data showed that the response rate of 100 mg group was 69.8%, 200 mg group was 76.6%, and methotrexate alone was only 48.9% In the finch 2 study, among the patients who did not respond adequately to the biological agent DMARDs, the response rate of ACR20 was 58% and 66% respectively at 12 weeks after taking the doses of 100mg and 200mg of filgotinib combined with DMARDs, while the response rate of DMARDs alone was only 31.1% In the finch 3 study, in a cohort of patients who had not used methotrexate, taking either 100 mg or 200 mg of filgitinib in combination with methotrexate achieved 80.2% and 81% response rates at 24 weeks, respectively, while the remission rate of methotrexate alone was 71.4% "Investors and doctors will inevitably make a comprehensive horizontal comparison of clinical data Even in the high-dose group, the efficacy of filgoinib may not seem so amazing compared with its future competitor, upadacitinib, which is the Jak1 inhibitor of Alberta, although filgoinib may be safer " Brian Abrahams, an analyst at RBC Capital Markets, commented in a report to clients after the disclosure of clinical data at finch 1 and finch 3 Merdad parsey, Gilead's chief medical officer, stressed in a conference call on the company's fourth quarter revenue that the combination of efficacy and safety of the drug was crucial "In an exchange of views with KOL, they appreciated the results and were excited about the combination of efficacy and safety of selective oral Jak1 inhibitors," parsey said Although filgitinib has excellent safety in human body, there are signs of testicular toxicity in the preclinical study In order to assess whether this phenomenon will affect humans, filgotinib is conducting testicular toxicity tests called manta-1 and manta-2, and we look forward to the final data As deep vein thrombosis (DVT) and pulmonary embolism (PE) events were found in clinical trials, xeljanz and olumiant, both JAK inhibitors, were labeled with black box warnings Upadacitinib seems to have shown good safety in its clinical trials, but FDA still added a black box warning to its instructions, suggesting that JAK inhibitors can cause DVT and PE If filgtotinib is exempt from the black box warning when it comes to the market, it will help to show the differentiation advantage of the drug, but analysts do not expect to do so at present "Although the clinical evidence from finch does not support this increase in risk, we still expect that filgotinib will be given the same black box warning as upadacitinib by FDA The current view of FDA is that JAK inhibitors may increase the risk of DVT / PE." Dane Leone, an analyst at Raymond James, speculated in a report to clients As an oral drug, filgitinib may have advantages over biological products that need to be injected, but O'Neill said she believes the benefits from convenience are very limited "The only really important difference for patients is the efficacy," she said "Very few patients are more inclined to take oral drugs when the two are equally effective." Gilead and Galapagos are also evaluating the efficacy of filgotinib in the treatment of ulcerative colitis, Crohn's disease, psoriatic arthritis and ankylosing spondylitis These five indications may be approved in the next four years The phase III clinical results of filgotinib in the treatment of ulcerative colitis are expected to be published in the second quarter of 2020 Currently, only xeljanz, a JAK inhibitor, is approved to treat the disease in the U.S market For Gilead, ulcerative colitis is easier than the competition for rheumatoid arthritis.