Update: FDA Approves Actemra to Treat Complication of CAR T Cell Tx
August 31, 2017 – The FDA has approved Actemra for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients aged ≥2 years, Genentech has announced. This marks the first FDA-approved treatment for this indication.
What’s the Problem?
Hundreds of patients died after taking the rheumatoid arthritis drug Actemra (tocilizumab injection), according to an investigative report published in STAT on June 5, 2017.
What is Actemra?
Actemra is an injectable medication that works by reducing the effects of a substance in the body that causes inflammation. The drug is approved to treat moderate to severe rheumatoid arthritis in adults, active systemic juvenile idiopathic arthritis (SJIA), polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older, and giant cell arteritis.
Arthritis Drug Linked to Hundreds of Patient Deaths, Report Finds
The STAT report found that hundreds of Actemra users had died since the drug was first approved in January 2010. Researchers analyzed data on more than 500,000 patients who took arthritis drugs, and found that those who took Actemra had just as high a risk of experiencing these side effects as patients treated with other arthritis drugs; however, most other competing medications warn about these risks, whereas Actemra does not. FDA has received at least 1,128 reports of death in Actemra patients.
Actemra Side Effects
Serious side effects of Actemra may include:
- Heart failure
- Heart attack
- Interstitial lung disease
Other common side effects:
- Runny nose
- Sinus pain
- Sore throat
- Stomach cramps
- Urinary tract infection (UTI)
Is There a Class Action?
Although we are a nationally recognized class action firm, the Pharmaceutical Litigation Group at our law firm has decided against the filing of an Actemra class action suit and is currently filing individual claims on behalf of individuals and/or their family members that have been injured by Actemra.
July 2008 – FDA Advisory Committee Recommends Approval
July 29, 2008 – FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis.
Sep 2008 – FDA Issues Letter
September 18, 2008 – FDA Issues Complete Response Letter to Roche for Actemra (tocilizumab) Biologics License Application.
Dec 2008 – Roche and FDA Agreement
December 4, 2008 – Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab).
Jan 2010 – FDA Approves Actemra
January 11, 2010 – FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid Arthritis.
Jan 2011 – Supplemental Approval Granted
January 5, 2011 – FDA Grants Supplemental Approval for Actemra (tocilizumab).
Apr 2011 – FDA Approves Actemra
April 17, 2011 – FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA).
Apr 2013 – FDA Approves Actemra
April 30, 2013 – FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis.
Oct 2013 – Genentech Gains FDA Approval
October 22, 2013 – Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra for use in Adult Patients Living with Moderately to Severely Active Rheumatoid Arthritis.
Jun 2017 – STAT report announcement
June 5, 2017 – STAT report announces that at least 1,100 deaths had been linked to Actemra. Researchers urge FDA to require warnings for heart failure, pancreatitis.
Nov 2007 – FDA Approval Application Submitted
November 21, 2007 – Roche Submits Application for FDA Approval of Actemra for the Treatment of Rheumatoid Arthritis.
- ”Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients”. STAT. June 5, 2017.
- FDA approves first drug to specifically treat giant cell arteritis. U.S. Food & Drug Administration (FDA). May 22, 2017.
- ”Actemra Approval History”. Drugs.com.
- “Actemra Drug Approval Package”. U.S. Food & Drug Administration (FDA).