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Praluent Brain Infections FDA

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anonymous

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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 the Amgen board:

"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.
 




anonymous said:
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.
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anonymous said:
This is serious shit! We are done!
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I am not sure I would say we are done, but you can take the 2016 sales forecast and divide by ten.

Physicians will still use it for patients with disease that is truly refractory to statins and lifestyle changes, but there will be big hurdles to jump. Managed care is not thrilled about paying for an expensive drug as it is, throw in the additional cost for managing potentially life-threatening side effects and the preapproval process will be brutal.
 




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.
 












However, that doesn't mean the new drugs are completely safe. Martin said the main concern that has arisen in trials of the new drugs is the potential for "neurocognitive effects." For example, some study patients reported problems such as confusion and trouble paying attention. But, Martin said, it's not clear yet whether the PCSK9 inhibitors are actually the cause.
 




there is a call scheduled with the FDA for later today to review multiple reports of sig A/E with PCSK9, both currently marketed drugs and the pfizer agent is involved. patients reported no memory and almost a sleep walking type of state while driving and operating equipment. this has been an area of concern during clinical trials and is part of the class's PMC. it's possible more information may be available by the end of today but certainly by tomorrow.
 




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.
 




















  • Denali   Dec 22, 2015 at 12:28: PM
anonymous said:
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.
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  • Denali   Dec 22, 2015 at 12:33: PM
The messages posted regarding Amgen and Regeneron PCSK9 products experiencing serious brain infection adverse events are a total fabrication. As such, those messages are a violation of US federal securities laws. Those who posted those messages should climb back under the rocks from which they came. The Securities and Exchange Commission is coming. Run.
 




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