FDA Rejects Biologic Drug for Rheumatoid Arthritis

Written by: Darren Young on Monday, November 21, 2016 Posted in: Specialty Pharmacy

uhohSarilumab, a promising rheumatoid arthritis drug in development by French drug maker Sanofi and New York-based Regeneron, was rejected by the FDA recently due to deficiencies at the plant where the drug’s syringes are filled.

This biologic treatment is intended for patients with “active, moderate-to-severe forms of [rheumatoid arthritis]” who aren’t getting adequate relief from available treatments. (1) In fact, recent data indicated that sarilumab was shown to be more effective than AbbVie’s popular Humira drug in “improving signs and symptoms” in patients with active RA. (2) This news gave struggling patients hope for more effective treatment of their RA.

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Unfortunately, during a routine review of the French plant where sarilumab is filled and finished, the FDA identified deficiencies in the facility’s good manufacturing practices (GMP) and issued a complete response letter (CRL) detailing the shortcomings. These must be resolved before the companies’ biologic license application can be approved. In response to the CRL, Sanofi says it has “submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions specified in that plan. Sanofi is working closely with the FDA toward a timely resolution that addresses these concerns.” (3) The response went on to say that the FDA’s citations were not related to the safety or efficacy of the drug itself.

While this news signals a disappointing delay in the availability of a new treatment that could bring relief to those who are getting little from current options, it’s also good to know that the FDA remains vigilant about GMP compliance. This should ensure that the new RA treatment, once available on the market, will be produced without defect and continue to be safe for patients.

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Source:
1- http://www.pharmatimes.com/news/fda_rejects_sanofiregenerons_sarilumab_1175096
2- http://investor.regeneron.com/releasedetail.cfm?releaseid=960092
3- http://investor.regeneron.com/releasedetail.cfm?releaseid=996179

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