Praluent Brain Infections

anonymous

Guest
The FDA informed Amgen and Regeneron today that there have been a number of post marketing reports of serious brain infection following the administration of PCSK9 agents. While they have not indicated any causal effect they have asked both manufacturers to prepare to attend a briefing at FDA after the new year. The agency has not indicated if they will issue any warnings or updates to the prescribing community as yet, there are 7 reports for repatha and 5 for pralulent. Amgen R&D is working thru the weekend to prepare for the meeting. It's not clear if the company will be sharing this with the field at this point. As I get updates I will share.
 












From Amgen:

Yes, this is the reported AE (PML), multiple reports for both drugs came in quickly post launch and they have also been seen in the Pfizer PCSK9 study. The agency has asked all three manufacturers for additional data from their clinical studies. At minimum this will lead to a rather challenging REMS and we can certainly expect a label change in the new year and at worse they could remove the products from the market. There were two calls with the FDA last week and the number of people at Amgen on the call is very limited and they do not plan to announce this to the company or field until after the call. It's highly problematic given PML outcomes and history in this area for other medications. There is another call on Tuesday so more data may be forthcoming.
 






"I can't comment on what actions the agency may take but can confirm that there is dialogue between the FDA, Amgen, Regeneron and Pfizer. It was driven by several post marketing reports and also observations from the Pfizer study. There was a meeting on Friday and at present no details will be shared until the FDA gives more clarity on what their concern is and what specifically they want. The initial AEs for Repatha came from two MD's in NYC, there have been subsequent reports from Dallas and from Orlando. More to come on both Monday and Tuesday."
 






"I can't comment on what actions the agency may take but can confirm that there is dialogue between the FDA, Amgen, Regeneron and Pfizer. It was driven by several post marketing reports and also observations from the Pfizer study. There was a meeting on Friday and at present no details will be shared until the FDA gives more clarity on what their concern is and what specifically they want. The initial AEs for Repatha came from two MD's in NYC, there have been subsequent reports from Dallas and from Orlando. More to come on both Monday and Tuesday."

Complete bullshit
 












This is not PML, I believe that was pure speculations by poster but to be clear PML can occur in any person who is in a compromised state, diabetic, transplant, cancer. This a profound neuro-cognitive effect being observed. There is a call scheduled this morning with R&D and one commercial person to prepare for a call with FDA and Bob Temple and Janet Woodcock tomorrow. That call is scheduled for 1PST. There is also information that an investigator has sent a letter to the editor for NEJM but it is not clear when that will be published. This is evolving rapidly and as more information comes in it looks increasingly serious for the category. Keep in mind this would be our second collapse due to CNS - recall our IL-17. FDA takes this AE very seriously particularly in the type of patient where a PCSK9 would be used, active patients.
 


















More details emerging this AM, the reports are of severe n/c impact. There were two patients involved in severe car accidents and one patient that suffered a sever injury operating power tools in their home. In each occasion they had no recall or memory of the incident. The other cases are less severe but all have the same theme. This was an area of great interest by the FDA during our clinical and labeling discussions and this looks like it will be problematic to label at minimum and use of drug going forward. More should come at 1PST. There was discussion about a communication to the sales people and to home office people but that has been declined for the present.
 






once again, complete B.S.
Posting the same message on both the Amgen and Regeneron boards within 15 minutes just shows you are an idiot. If you are trying to manipulate stock prices, stay on the yahoo boards.
 












Looks like someone shorted regn and amgn and have successfully created a brief dip in both stocks with bullshit rumors.

PCSK9 inhibitors are not immunosuppressors, the idea that they might make on vulnerable to infection of any kind is not consistent with the characteristics of the antibodies.
 












UBC, an Express Scripts company is responsible for taking all the AE's. UBC and ESI are corrupt, greedy, incompetent and crooked. So, if they say there has only been 12 brain infections, I bet my life that there has been 24. ESI is unethical, incompetent and crooked. I am a licensed medical professional and an employee and it is very sad. All I can say is buyer beware and be your own advocate.