Honestly I feel a very big chunk of it.
Compared to Fabrazyme it has at least equal efficacy and superiority in safety. That was in the clinical trial setting. But in the real world Elfabrio would have greater efficacy as we should remember that these patient came into the Balance trial with a terrible mean -8 eGFR slope despite being on Fabrazyme already for years.
I would not understand if being the treating physician why I would not put my more severe/classical patients on Elfabrio due to the efficacy, and I would not understand why I would not put the same classical as well as my other patient on Elfabrio due to the efficacy and safety.
Now this is compared to Fabrazyme.
Now let's consider vs Replagal, where Elfabrio results were incredible both on efficacy and safety again.
Now let us also consider this from a patient perspective. Which treatment would you rather be on? You have a choice of equal or better efficacy with better safety, for a drug that you will take every 2 weeks for the rest of your life and which is keeping you alive.
This is evidenced by the Balance clinical data vs Fabrazyme.We note that in this vs Fabrazyme trial, 97% of the patients completing the trial, 96% (45 of 47) in the Elfabrio arm opted to continue on Elfabrio, and also the 100% (24/24) of the Fabrazyme arm patient opted to initiate on Elfabrio.
The physician and patient community is small and well informed. I expect Elfabrio to make strong sales. To support this we should also note that Chiesi is a strong and well recognised partner, I would expect swift ramp-up with strong continuation of efforts. Time is money. All parties are strongly incentivised to maximise sales.
I would expect Elfabrio to take at least 50% of the US market as it will be the only other option to Fabrazyme, if approved of course, (I think we can ignore Galafold, after so many years they are only treating just about 1000 patients globally). Elfabrio would also take about 50% of the Fabrazyme market in Europe.
But in Europe I would expect Elfabrio to take another 50% from the Replagal market. Hence I would expect Elfabrio to be the dominant player in the EU.
Again just think about, as a physician and patient, why would you not switch to Elfabrio?
While I am not a Fabry patient, I would be almost certain that if my insurance covered both Elfabrio and Fabrazyme, I would most certainly want to be on Elfabrio. The Balance was a trial that was a switch from Fabrazyme, so I would feel very comfortable knowing that this would directly relate to me.
If I were the physician, I might be even more prone to switch my patient because of the clear data proven safety benefits and avoid getting sued in the future.
Again, I would like to hear any reasons as to why not switch to Elfabrio (assuming insurance coverage of course).
AI
