The FDA recently granted an emergency use authorization for a new Covid prophylactic for the immunocompromised. It's called Pemgarda and it is administered intravenously. It's like the former Evusheld in that it gives us antibodies (which is great for those of us who don't respond well to Covid vaccines), but unlike Evusheld it neutralizes the current variants. This great news for those of us who have been living relatively isolated lives for so long.
We finally have a new Evusheld! - Kidney Transplant
We finally have a new Evusheld!
Many, if not all, of us share your excitement. Please see the post from 13 days ago.
Thus far, there is relatively little information available on Pemgarda. I contacted my nephrologist shortly after hearing the news, and they are, likewise, waiting for more information. They will contact me if/when it becomes available at their transplant center.
I am also waiting for news from AstraZeneca on results from its Supernova trial on AZD3152, the updated version of Evusheld. In vitro tests have shown it to neutralize all Omicron descendent variants that have appeared so far. They have said that they would seek emergency use authorization from the FDA promptly if the clinical studies confirm the lab results (and prove safety of the treatment).
Considering the difficulties some people had obtaining doses of Evusheld, it would be great if there were more than one mAb treatment available for the entire immunocompromised community (not just us transplantees).
Waiting impatiently...
There was just a press release that Pemgarda is now available for purchase. CMS codes are still needed for insurance.
I'm in the Supernova trial but think it will be some time before AZ submits its data for an EUA, so I plan to get Pemgarda.
March 22 this new drug "Pemgarda" was FDA approved, so I went and dug deeper into the study that led to its approval. From what I learned, my spouse will not be taking it. Too few volunteers in the study and around 33 of the people out of 686 were whole organ transplant in the study. Not comfortable with this low number. Plus the drug is not being produced in enough quantity to be available to everyone wish to take it, just like what happened with Evushield. Our transplant nephrologist was not approving to take Evushield due to their knowledge of the study. Everyone needs to make up their own minds. Do your own research. I wish you all a good day.
You're absolutely correct, and the same was true of the Evusheld trial.
Given Pemgarda's efficacy in the immunocompetent, in vitro, and the low infection rate in the immunocompromised, I'm planning to take it as I generated no antibodies from my (many) Covid vaccines and I look forward to actually having neutralizing antibodies.
As for access problems with Evusheld, remember that Evusheld was purchased and distributed by the government because that was during the Federal Health Emergency. My own transplant center initially had so few doses that Evusheld was given only those transplanted within the past few months. I had to drive 200 miles to a place where I could get it. That emergency expired last year and Pemgarda is ordered commercially, like any other drug. I hope access will be far easier than it was for Evusheld!
I started calling my doctors immediately. They hadn’t even heard of it. My rheumatologist said oh it’s for people who have Covid as a treatment . Ummm no it is not! It’s preventative. Sucks because he’s the dr I got evushed from.