Gates Package — page 57

Casco, Tony (NIH/NIAID) [C] From: Hu-Primmer, Jean (FDA/OC) Sent: Friday, July 25, 2014 10:13 AM To: Olinger, Gene (NIH/NIAID) [C]; Hensley, Lisa (NIH/NIAID) [E]; Honko, Anna (NIH/NIAID) (E] Subject: RE: today's Ebola MCM working group Hotly debated here at FDA too -- this is part of the reason why DAVP does not want to comment on the already approved drugs for re-purposing because most are oral and they say that oral is not the way to go because as you say -- cases arrive late and will not tolerate oral doses. And we know that MSF is using IV therapies (ie |V rehydration)... Already approved drugs don't mean anything if we are changing route of administration of doses (because the some of the therapeutic windows are too narrow for EBOV).... If we change the dose or route the existing human safety information is questionable (may not be applicable). From: Olinger, Gene (NIH/NIAID) [C] [mailto Onih.gov] Sent: Thursday, July 24, 2014 11:39 AM To: Hu-Primmer, Jean; Hensley, Lisa E (NIH); Honko, Anna N (NIH) Subject: RE: today's Ebola MCM working group Honestly, at this point, cleaning the area is difficult. So there are many logistical/clinical issues. Injections, needles, etc. are an issue but IV is commonly done with Lassa cases (is how they administer ribavirin). Limited physical contact is preferred. In other conversations, oral administration is likely not ideal either as cases arrive late in disease and may not tolerate doses by oral route. Lisa or Anna may want to comment on this topic as this is a hotly debated area. May even want some of the clinicians who have been there or there to comment as I am sure there are local differences. Gene From: Hu-Primmer, Jean (FDA/OC) Sent: Thursday, July 24, 2014 10:07 AM To: Olinger, Gene (NIH/NIAID) [C]; Hensley, Lisa (NIH/NIAID) [E]; Honko, Anna (NIH/NIAID) [E] Subject: RE: today's Ebola MCM working group I will circulate your thoughts within the Division, as well as the excel spreadsheet -- see if they have any ideas. I will also ask Gary to consider convalescent IVIG since this Friday's conversation will be CBER-related and polyclonals are in their shop. I understand that because the field "hospital" conditions are very austere, there is a concern about the feasibility for any IV treatment with concerns of ancillary supply availabilitiy and potential for needlesticks etc.... was that raised during the WHO call? Thanks, Jean