Pen injector for Besremi in the US

[Joey1025]

Today I saw news on PharmaEssentia's website stating that they have applied in the United States to launch a pen Injector for Besremi.

I think this is a good development? I've seen the Pen Injector used in Europe by another company AOP health for Besremi, and it seems much more convenient than the syringes used in the US. Easier to administer, and can set the dose more accurately.

I wonder why PharmaEssentia didn't initially apply to market the pen injector in the US at first place? I've seen my brother struggling with the syringe for a few time. It would have saved a lot of troubles for the patients in the US. Anyways, if they receive FDA approval, American patients can also use this more convenient method 😁

[EPguy]

PharmaEssentia FDA application was initially rejected (2021) in part bec of defects in the instructions. My assumption at the time was they went to a simple syringe to side step that rejection. So this could be a redo to address those FDA rejections.

The Euro pen is authorized for more than one use, will be interesting if that comes to the US.

AOP is actually the guys that ran the Bes trials and enabled its approval in Euro and here. AOP sued the Taiwan mfr in Euro bec the mfr (called PharmaEssentia in the West) tried to go around AOP distribution after AOP spent all that money on trials. I think PharmaEssentia has direct rights in the US.

[Grapefruitlohoff in reply to EPguy]

Sad to see disputes between companies took away benefits from the patients. They would have been able to enjoy better treatment it seems.

[EPguy in reply to Grapefruitlohoff]

From what I know, there was no effect on Euro pts access to Bes, just a behind the scenes dispute. In this case AOP won the arbitration, so their name shows up in Euro Bes materials.

It is a good reminder how expensive it is to bring new drugs to market, with the cost of trials etc, esp as most are duds. The dud rate is supposedly improving with better trial design and drug design tech. We'll find out how well new tech is going if INCB160058 (the Jak2 targeted inhibitor of recent post) advances from its phase 1.

[Grapefruitlohoff in reply to EPguy]

Thanks for clarification. I thought it was because of the dispute that the same injector was not introduced to the US market. For the new Jak 2 inhibitor trial, it's always good to see new options become available. Looking forward to it.

[Spoalllen in reply to EPguy]

Ｉthink PharmaEssentia own the license of Besremi.

[Grapefruitlohoff in reply to Spoalllen]

Not in Europe. In Europe the marketing license is owned by AOP.

[Aldebaran25]

I am in Europe and use the pen. It is easy to set but tbh , I preferred the syringe which I used when on Pegasys. I find that with the pen sometimes I am unsure whether I have injected at all and once I had a faulty needle part (which is a contraption with a retracting protection piece) that did not function properly . A problem since there are only two needles per pack. In essence, I prefer the simple and more “direct” syringe.

[EPguy in reply to Aldebaran25]

to Aldebaran25

Your trouble may be one reason the US FDA apparently rejected the Besremi application using the pen. We've not heard to from too many Euro users of the pen. The pen is authorized for more than one use if the dose is not over 100 or 250mcg depending on which pen, according to the Euro label. I guess that is why it has two needles. Is that familiar, or are you instructed just for one use?

[Aldebaran25 in reply to EPguy]

I use one pen for two doses and I inject every two weeks. According to the leaflet, once opened , the product can be kept for a max of one month. I imagine that the needle part is designed to prevent the contamination of the product inside the body of the pen, as well as allowing a quick and safe injection mechanism. However, as mentioned, it is much more complicated than a simple needle and in my experience it malfunctioned once over a period of five months i.e. one out of ten injections.

[EPguy in reply to Aldebaran25]

My understanding of the pen is similar to a prefilled syringe, but with more features to make it easier for "better accuracy and for people with dexterity issues or visual impairments". They hide the needle to make it look friendlier. From your experience these features can add complexity and failure points while pts without these disabilities could make a basic syringe work as is known outside EU and with Bes.

But with the current PEG shortage the authorized multi-use pen could be quite useful.

[Aldebaran25 in reply to EPguy]

Yes totally, that’s precisely what I mean. The pen is pretty cool but more prone to faults.