A European Medicines Agency panel said on Friday it recommended granting marketing approval to Sanofi and Regeneron’s experimental drug to treat rheumatoid arthritis.
The Committee for Medicinal Products for Human Use gave a positive opinion on the drug, Kevzara, citing its ability to reduce the signs and symptoms of rheumatoid arthritis.
Sarilumab, the active substance of Kevzara, a treatment for adult patients with moderate to severe rheumatoid arthritis, works by blocking a protein called IL-6, which is associated with inflammation.
The panel’s opinion will now be reviewed by the EMA.
In October, U.S. regulators declined to approve sarilumab because of manufacturing deficiencies at a Sanofi plant in France.
Regeneron said in February that it was planning to resubmit a marketing application to the U.S. Food and Drug Administration for sarilumab.
The drug has already been approved by Canadian health regulators to treat rheumatoid arthritis.
More than 23 million people worldwide suffer from rheumatoid arthritis. Current treatments include the widely used methotrexate as well as non-steroidal anti-inflammatory drugs.
Other IL-6 inhibitors for rheumatoid arthritis include Roche Holding AG’s approved Actemra and Johnson & Johnson’s experimental sirukumab.
Last Friday, the FDA declined to approve a new rheumatoid arthritis drug, Olumiant, made by Eli Lilly and Co and partner Incyte Corp.
Related Posts
Post Disclaimer
Professional Scope of Practice *
The information herein on this entire blog site is not intended to replace a one-on-one relationship with a qualified healthcare professional or licensed physician and is not medical advice. We encourage you to make healthcare decisions based on your research and partnership with a qualified healthcare professional.
Blog Information & Scope Discussions
Our information scope is limited to Chiropractic, musculoskeletal, physical medicines, wellness, contributing etiological viscerosomatic disturbances within clinical presentations, associated somatovisceral reflex clinical dynamics, subluxation complexes, sensitive health issues, and/or functional medicine articles, topics, and discussions.
We provide and present clinical collaboration with specialists from various disciplines. Each specialist is governed by their professional scope of practice and their jurisdiction of licensure. We use functional health & wellness protocols to treat and support care for the injuries or disorders of the musculoskeletal system.
Our videos, posts, topics, subjects, and insights cover clinical matters, issues, and topics that relate to and directly or indirectly support our clinical scope of practice.*
Our office has reasonably attempted to provide supportive citations and has identified the relevant research studies or studies supporting our posts. We provide copies of supporting research studies available to regulatory boards and the public upon request.
We understand that we cover matters that require an additional explanation of how they may assist in a particular care plan or treatment protocol; therefore, to discuss the subject matter above further, please feel free to ask Dr. Alex Jimenez, DC, or contact us at 915-850-0900.
We are here to help you and your family.
Blessings
Dr. Alex Jimenez DC, MSACP, RN*, CCST, IFMCP*, CIFM*, ATN*
email: coach@elpasofunctionalmedicine.com
Licensed as a Doctor of Chiropractic (DC) in Texas & New Mexico*
Texas DC License # TX5807, New Mexico DC License # NM-DC2182
Licensed as a Registered Nurse (RN*) in Florida
Florida License RN License # RN9617241 (Control No. 3558029)
Compact Status: Multi-State License: Authorized to Practice in 40 States*
Graduate with Honors: ICHS: MSN-FNP (Family Nurse Practitioner Program)
Degree Granted. Masters in Family Practice MSN Diploma (Cum Laude)
Dr. Alex Jimenez DC, MSACP, MSN-FNP, RN* CIFM*, IFMCP*, ATN*, CCST
My Digital Business Card
