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FDA accepts sarilumab BLA; PDUFA date October 30

Source Link:: http://files.shareholder.com/downloads/REGN/959541530x0x869189/61C73EB5-02A0-48D4-BE50-FB2EF1FECE32/REGN_News_2016_1_8_General_Releases.pdf

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Additional Information

Additional Relevant Details Sarilumab is an investigational, human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA). IL-6 is the most abundant cytokine in the serum and synovial fluid of patients with RA and levels correlate with both disease activity and joint destruction. The BLA for sarilumab contains data from approximately 2,500 adults with active, moderate-to-severe RA who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA Phase 3 program.

http://files.shareho...

Management Comment "Given that the CGMP status of this facility is under review by the FDA, it is unclear whether or how this situation may impact the timing of the potential approval of sarilumab by the FDA."

10/28/2016

https://www.sec.gov/...

Additional Relevant Details FDA Rejects Sarilumab

http://seekingalpha....

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Catalyst Date

Occurred on:

Oct 28, 2016

Occurred Source:

http://files.shareholder.com/downloads/REGN/3112949479x0x914383/2087FE4E-4114-4AB7-B29E-939BAD979F4A/REGN_News_2016_10_28_General_Releases.pdf

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Related Keywords Fda, Sarilumab, Bla, Pdufa