One step away! Sanofi and sarilumab, a rheumatoid arthritis drug, were rejected by FDA

Source: introduction to Sina medicine 2017-03-10: in March this year, sarilumab, a phase III clinical bulletin, was a drug for rheumatoid arthritis under Sanofi and Zaiyuan The test showed that its therapeutic effect was superior to that of the star drug xiumeile Today, however, the FDA's rejection letter broke people's expectations and was only one step away from mass production ▲ the picture is from Sanofi According to the report on pharmatimes website, the US FDA recently issued a complete response letter, emphasizing that some obvious defects were found in the routine production specification inspection of a pharmaceutical factory of Sanofi The pharmaceutical factory, Sanofi Le trade facility, is the factory that completes the filling and processing of the rheumatoid arthritis drug sarilumab, and the drug filling is the last step in the production process A Sanofi spokesman said that they are taking corrective measures and working closely with the FDA to find solutions in a timely manner ▲ the picture is from European Pharmaceutical review sarilumab, a monoclonal antibody of human origin, which targets IL-6 receptor, and is used to treat patients with rheumatoid arthritis (RA) in deteriorating or moderate to severe conditions The human trial of the drug involved 2500 patients, who had no significant response to the previous trial scheme, including 7 projects from the global saril-ra phase III project Recent data from the saril-ra-target study showed that compared with placebo, it achieved the main efficacy point in improving the symptoms and physiological functions of patients with rheumatoid arthritis, and was rated as "clinical related data significantly improved" In January of this year, the two companies announced that FDA accepted the application for biological product license (BLA) of the drug, and designated the target date of PDUFA as October 30, 2016 Now the arrival of November means that this goal has been lost, and the review in Europe is also in progress, perhaps with new hopes to be expected Reference: [1] FDA refects Sanofi / regeneron's sarilumab [2] sarilumab demonstrates priority to adalimumab in rheumatoid arthritis [3] Sanofi and regeneron announcement sarilumab biology license application accepted for review by US FDA