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Going Up Against AbbVie (ABBV)'s Humira, Johnson & Johnson (JNJ) Presents Less-Than-Stellar Phase III Data



11/14/2016 5:57:11 AM

Going Up Against AbbVie's Humira, Johnson & Johnson Presents Less-Than-Stellar Phase III Data November 14, 2016
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON – Shares of Johnson & Johnson (JNJ) and GlaxoSmithKline (GSK) are down this morning after the companies presented data of the jointly-developed rheumatoid arthritis drug sirukumab demonstrated mixed-results when compared to AbbVie (ABBV)’s blockbuster drug Humira.

Data from a Phase III head-to-head trial showed that in some instances, certain dosing levels of sirukumab outperformed Humira, but in other comparisons sirukumab did not do as well, Reuters reported this weekend. Half of the trial’s patients taking a dose of 50 milligrams every four weeks and 100 milligrams every two weeks achieved statistically significant responses in reducing RA symptoms, compared to Humira. However, J&J reported that the portion of patients who achieved those responses was not significantly statistic across all groups, Reuters said. The data was presented at American College of Rheumatology meeting in Washington, D.C. over the weekend.

Sirukumab is a human monoclonal IgG1 kappa antibody that targets the cytokine IL-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like.

In September, Janssen Biotech (JNJ), a subsidiary of Johnson & Johnson, submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis. The company, which has been developing sirukumab with GlaxoSmithKline since 2011, submitted the BLA based on Phase III data, which included five separate studies. Phase III data showed patients receiving sirukumab “demonstrated significant inhibition of radiographic progression, or joint destruction, from baseline to week 52 and improvement in signs and symptoms of RA at week,” meeting the primary endpoints of the trial.
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Rheumatoid arthritis is a chronic, systemic inflammatory condition that impacts about 23.5 million people worldwide. There is no cure for RA.

While the Janssen and GSK results are mixed, that does not mean the FDA is not likely to reject the BLA—not like what happened to another jointly developed RA treatment. In October, the FDA sent a Complete Response Letter to Sanofi (SNY) and Regeneron (REGN) regarding the rheumatoid arthritis drug sarilumab. The FDA objected to the drug due to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished, Regeneron said in a statement on Friday. Sanofi said it was addressing the issues cited, which are one of the last steps in the manufacturing process. The French company has filed a comprehensive corrective action plan with the FDA and “working towards a timely resolution that addresses these concerns.” Once the issues are addressed, both companies said they intend to seek a way to bring the drug to market.

Data from a Phase III trial released in March showed that sarilumab outperformed AbbVie’s Humira. Regeneron and Sanofi said its experimental sarilumab improved the signs and symptoms of rheumatoid arthritis (RA) patients after 24 weeks of use.


Read at BioSpace.com


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