FDA Approves Kevzara® (sarilumab) for Moderate to Severe Active Rheumatoid Arthritis

FDA Approves Kevzara® (sarilumab) for Moderate to Severe Active Rheumatoid Arthritis

By Staff.

The U.S. Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of moderate to severe active rheumatoid arthritis (RA).

“In the clinical trial program, sarilumab demonstrated statistically significant, clinically-meaningful improvements in adult patients with rheumatoid arthritis by reducing signs and symptoms and improving physical function, resulting in significantly less radiographic progression of structural damage of RA,” said Alan Kivitz, M.D., CPI, Founder and Medical Director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center, and an investigator in the global SARIL-RA clinical program for sarilumab. “This is important because not all currently available treatments work in all patients, and some patients may spend years cycling through different treatments without achieving their treatment goals. Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF class, and is a welcome new option for patients and their physicians.”

Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with RA.

“Despite the many advances made in the treatment of rheumatoid arthritis, patients continue to need new treatment options,” said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. “Today’s approval in the U.S. not only underscores our ongoing commitment to making a difference in the lives of patients, but also demonstrates our drive to accelerate science and medicine in immunology.”

Kevzara may be used as monotherapy or in combination with MTX or other conventional DMARDs. The recommended dosage of Kevzara is 200 mg once every two weeks given as a subcutaneous injection, which can be self-administered. The dosage can be reduced from 200 mg to 150 mg once every two weeks, as needed, to help manage certain laboratory abnormalities (neutropenia, thrombocytopenia, and liver enzyme elevations).

The approval of Kevzara was based on data from approximately 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens. In two pivotal Phase 3 clinical trials, Kevzara plus background DMARDs demonstrated statistically significant, clinically-meaningful improvements in patients with moderately to severely active RA.

“Today’s milestone with Kevzara, which follows closely on the heels of our recent approval of Dupixent (dupilumab), showcases the ability of our internal discovery and science engine to deliver important new medicines by leveraging our leading technologies, such as VelocImmune,” said George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron. “This milestone would not have been possible without our important ongoing collaboration with Sanofi, and most importantly, the patients and physicians who participated in our SARIL-RA clinical program, and worked with us to make Kevzara available to those in the U.S. RA community in need of new options.”

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Authored by: Staff

There are 5 comments for this article
  1. Jean Price at 8:46 pm

    There are significant side effects from ALL the disease modifying medications to treat RA and to prevent more progressive damage to the body. Yet it’s a quality of life issue, I think. So although decades from now we may see these drugs caused some problems….they still have allowed some people to function at a better level than without them! The risks are real…but so is the symptom relief they offer…and it’s an individual decision. Having them available is important to many people…having newer ones is a plus my opinion!

  2. janice at 4:01 am

    absolutely agree whole heartedly. Whatever any chronic pain patient s future holds for that individual. It seems that one common bond will be no relief.

  3. Kat Mansfield at 5:41 pm

    Why not start a national paint report for those who don’t suffer from Pain and have been cut off and for those who have not been cut off or have found a rare doctor that will prescribe when they clearly see proof of a problem
    You would be able to discuss some less miserable problems that deal with pain.
    And can ignore those so miserable and tossed away by mainstream doctors.
    Clearly people need to say their peace. As we crawl and cringe thru minimal movement and restrictions few can imagine.
    With real respect to RA patients..this looks like another .edicine with limited info.
    Side effects are not even mentioned. People who are suffering are vulnerable no matter what their problem is period we see sites like this and we want to believe they are trustworthy. I used to bring my doctor the name of a new antidepressant every month or two. Because I knew antidepressants could help me deal with pain but I’m allergic badly very badly to most of them. So far. Cymbalta, Lyrica, Gaba something(neurotin?)- all made me itch, tremble,continally gag, or ..after a single dose FINALLY STOPPED pbysically abusing me..left me in a deep black hole that was terrifyingly bleak with hopelessness being central -in the lock-down from functioning,overall.

    This RA medication may be gambling with the immune system. But I do realize people get desperate because I am. And had I not had a near-complete immune system failure, I would not blink at trying this if I was at my breaking point and I am at that point. But being who I am I would probably be sick with the first dose..in 30-60 minutes.
    It does seem like we’re unwelcome because we don’t even get a reply that ‘you can’t be involved’-or you ‘wish there was something you could do.’
    God bless us all and may we somehow find a way out of this deep black hole, that has been thrown at the weakest, and the most precious people. People in general- don’t deserve to be mistreated. yes the group in the “criminal potential” group includes elders and Veterans and people have worked hard and suddenly stopped by accidents. Or, their deformities, conditions, or diseases have gotten the best of them. Sometimes its after an accident or a bad surgery..other times its effects just spiral down too far on us.

    We Can’t Fight for ourselves. We can’t call politicians and avoid getting into a screaming match with a secretary blocking us cold. Because we’re in pain we have triggers..and we eventually give up on using a phone because we don’t want to be seen as crazy. If thats possible.
    Just because we’re wincing in squalor of pain/isolation/cluttered surroundings/ in need of a little help we are not criminals about to overdose as media now implies so recklessy with NO BASIS.
    BUT..We also cant organize our mail..let alone start a movement.
    So the weak shall NOT inherit the earth.
    But maybe in ANOTHER FEW YEARS IN LOCKDOWN AND FEARS.. we might SEE enough abuse to elders in the numbers of suicides.
    To cause a few able activists to START PROTESTING.yes I am a dreamer..am not the only one.
    I dont even read these updates from many resources for simple info..because medication updates are now released more recklesslymore often.. but the price, with less research, — is higher. As the risks are commonly cancer or death.
    I cant take it in. Others dont seem to react. Desperation runs deep.

    May those who are not in pain, + who tire of intrusions here, by the most pained/most ignored…- have a nice day.
    May those in life-stopping pain have smallest yet critical prayers be answered..starting on what is a Day of Rest. Today.
    Since We -dont even rest much..Even non opiates, such as Ambien are now part of the ”Dont Allow to those who are suffering the most.” Sickeningly sadistic. No overdoses from long term patients..but abuse them anyway!! make them some cruelly twisted example. Gaining deep shame and nothing more.
    Others dont want to help pain patients. We are NOT ADDICTS as defined clearly..but we take drugs..so somehow those in pain are suddenly USERS in the worst assuming way.
    I could gon on..but I already have just taken up space.
    Unless another warrior might reach out..+ reply.
    Not overdosing yet..not wanting to die either. After 26 years. Never took extra doses or “ran short.” But punish us all like street zombies, shooting, using garage drugs, who ROUTINELY DO -OVERDOSE. Yes everyone agrees.. a few weeks lead elders etcetera to a certain O.D. + forget street addicts.. just go after tbe non-street well regulated patients. blame the weak who suffer..and PRETEND that the prescribed, closely monitored, pain stricken hjmans..need to BE poster-pain adults ( not kids) with horrific illnesses. Make us pay. Ignore random complaints.

    Yes, indeed, I am a loser -alone and real scared. Not a shred of help or support.
    Now I am in pain for ranting. Had more fun with an old fashioned, neddle-poking, EMG.

  4. Michael Langley at 5:35 pm

    Immune therapy will end with a much higher death rate than opioid therapy. Too bad people are given the choice between pain therapy or risking death!

  5. Ibin Aiken Talong at 1:33 pm

    It would be better to be a “lab rat”, right now rather, than a chronic pain patient. Removal, at least temporarily or amend radically the “mis-guided- line being enforced by the CDC UNTIL effective, available, affordable means of severe chronic pain control is “acceptable” to the VERY FORTUNATE that do NOT have to contend with severe, continuous, insufficiently prescribed pain management patient treatment received at this time. Torturous, sadistic, measures in the “attempt” to sway the “social conscience” of DRUG ABUSE will NOT be successful with those experiencing “out if management”, non “curable” bodily impaired causes of severe PAIN.

    Not a d*** agency is willing to receive accurate patient information to those of us DIRECTLY., diversely affected with current opioid prescribing “guidelines, at all.One shoe fits all with dosages of pain control management medications are insufficient AND we don’t have a voice, or matter.

    A baby aspirin is given up to a certain age. We don’t give 20 milligrams of insulin to a mild diabetic. The same health prescribing medication due diligence SHOULD apply to the INDIVIDUAL chronic pain health condition. I believe in mode-racy prescribing for a health condition, not insufficiency to ALL Using first, less strength medication for ALL pain control but, some of us, millions patients HAVE no other method of treatment except the proper medication, at the sufficient, proper dosage to remain physically, healthy and mentally sound other than “how” the educated physician using due diligence,lawfully monitored, is ALLOWED to prescribe at THIS time. It is dangerous to the the patients health and is negligently being totally, IGNORED It IS willful negligence in the individual patients healthcare, period.

    The different needs to be prescribe medication sufficiently to different variations of chronic pain prescribing has been adopted as ” the one shoe fits all” prescribing to one and all. It is harmful, ignorant, asinine policy of prescribing with the patients INDIVIDUAL needs at any one point of treatment, in their perspective point in time and is being ignored though causing hardship and suicide with the mis-guide-line enforced and published by the CDC. Evidently the authors, the “experts”, and the constitutes are not in chronic pain nor have a family member suffering or they just don’ give a damn.