Sanofi / regenerant heavyweight rheumatoid drug sarilumab approved by FDA

Source: on May 25, 2017, Sanofi and sarilumab, the heavyweight drug of shengshengshengyuan, were approved by FDA for rheumatoid arthritis treatment Last year, the drug was rejected by FDA This interleukin-6 (IL-6) inhibitor, under the trade name of kevzara, has been rapidly marketed for the treatment of moderate to severe rheumatoid arthritis patients with one or more anti rheumatic drugs, such as methotrexate, which can improve the condition Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease that attacks joint tissue, causes inflammation, pain, and ultimately joint damage and disability This disease affects about 1.3 million people in the United States alone Kevzara is a human monoclonal antibody, which can bind to the interleukin-6 receptor (IL-6R) The drug shows that it can inhibit IL-6R mediated signal transduction Over time, IL-6 can cause inflammation associated with rheumatoid arthritis The approval is based on data from about 2900 adults with moderate to severe active rheumatoid arthritis who have not responded adequately to previous treatment regimens The results show that the drug leads to a statistically significant and clinically significant improvement in patients with the disease Sarilumab is the second IL-6 inhibitor to enter the U.S market after rodrigzumab (trade name: actemra) Actemra was first launched in 2010 At present, it has become a best-selling drug of Rodriguez Its sales volume last year was about 1.7 billion US dollars Sarilumab claims to be ahead of GlaxoSmithKline and sirukumab of Johnson & Johnson The listing application of the latter was made in September last year Submitted in the month of Kevzara has a dose advantage compared with Roche's drug There are two ways of administration of toluzumab: intravenous injection or subcutaneous injection, once a week, while sarilumab once every two weeks Sirukumab can be used once a month, according to GlaxoSmithKline and Johnson & Johnson Sanofi and Zaihuan also expect their competitive prices to make progress in the market, where new drugs have to compete with mature TNF inhibitors and new, cheap TNF biological analogues The two companies set a price of $39000 a year for kevzara, which they say is about a third lower than the two most widely used TNF blockers, Aberdeen's sumac and Amgen's inarcept According to a recent report from the American Institute of clinical and economic review, the price of the main TNF blocker used in rheumatoid arthritis has risen in recent years, and its price has exceeded the upper limit of cost-effectiveness The report said regulatory intervention may be needed to prevent future price increases Kevzara's low price suggests that market forces may also start to play a role Kevzara was approved in Canada earlier this year, and last month the European Drug Administration's human Products Committee recommended approval for the drug Yesterday's good news came from Roche The FDA approved actemra for giant cell arteritis, its sixth indication This approval makes it the first drug approved for this serious autoimmune disease in the United States Giant cell arteritis can cause headaches, jaw pain, and visual impairments, and if not treated, it can lead to blindness, aortic aneurysm, or stroke.