Regeneron and Sanofi announce sarilumab BLA Accepted for review by FDA
Sarilumab is an investigational, human monoclonal antibody intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis
Regeneron Pharmaceuticals and Sanofi have announced that FDA has accepted for review the Biologics License Application (BLA) for sarilumab. Per the Prescription Drug User Fee Act (PDUFA), the target action date is 30 October 2016. Sarilumab is an investigational, human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA). IL-6 is the most abundant cytokine in the serum and synovial fluid of patients with RA and levels correlate with both disease activity and joint destruction.
The BLA for sarilumab contains data from approximately 2,500 adults with active, moderate-to-severe RA who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA Phase III program.
The goal of the ongoing global clinical development program is to evaluate the safety and efficacy of subcutaneous sarilumab, either as monotherapy or in combination with conventional disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX), in reducing the signs and symptoms and inhibiting the radiographic progression of RA.
The safety and efficacy of sarilumab have not been fully evaluated by any regulatory authority.
Related News
-
News Federal judge blocks Colorado's unprecedented price cap on Amgen's Enbrel
A US federal court has halted Colorado's attempt to impose a US$31,200 annual price cap on Amgen's arthritis drug Enbrel, ruling that the pharmaceutical company would likely suffer irreparable harm. The decision represents a significant blow to... -
.png)
News Protecting life-saving therapies: CPHI Online Podcast Series
The latest episode of the CPHI Podcast Series dives into a critical challenge facing the pharmaceutical industry: ensuring the integrity of temperature-sensitive medications and biologics through advanced predictive technology.
-
News 2026 Outsourcing Outlook Update - pharma at a crossroads
The pharmaceutical contract development and manufacturing organisation (CDMO) sector is experiencing unprecedented transformation, driven by evolving therapeutic complexities, geopolitical tensions, and the growing demand for specialised manufacturing ... -
News Roche maintains German investment commitment whilst rivals scale back
Pharmaceutical giant Roche has reaffirmed its commitment to investing in Germany, standing firm even as competitors Eli Lilly and Boehringer Ingelheim dramatically reduce their planned investments in response to controversial healthcare reforms.
-
News Women in Pharma: The History of CPHI Women in Japan
Our monthly Women in Pharma series highlights the influential lives and work of impactful women working across the pharmaceutical industry, and how the industry can work towards making the healthcare industry and workplace more equitable and inclusive. -
News EU drafts deal to end essential medicines shortage
European negotiators have agreed new legislation to tackle persistent shortages of essential medicines by prioritising supply security over price in public procurement and supporting domestic pharmaceutical manufacturing with strategic funding.
-
News Thermo Fisher Scientific offloads microbiology business to PE firm Astorg
The life sciences giant is divesting its global microbiology unit, which generated $645 million in revenue last year, to the pan-European private equity firm as part of an active portfolio management strategy. The transaction is expected to close in th... -
News The Shift: Why Sustainability is Moving to the Centre of CPHI Milan 2026
CPHI Online contributor David Roach takes a look at how conversations around sustainability in the pharmaceutical industry can and must be transformed into actionable deliveries, and what the inaugural CPHI Sustainability Summit means for the industry.