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Post by bradleysbest on Jul 2, 2015 11:04:27 GMT -5
The SA article refers to Afrezza being in stage 3 clinical trials. I heard that EU approval is usually easier & that they often follow the lead of the FDA. Any idea as to when we can expect Afrezza to be approved in the EU?
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Post by ashiwi on Jul 2, 2015 11:15:11 GMT -5
Sanofi has to submit for approval 1st. We still don't know if that's even been done.
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Post by mnholdem on Jul 2, 2015 12:21:57 GMT -5
Last year, I read up pretty extensively on the EMA process. I would not necessarily agree that EMA centralized authorization is any easier, but it certainly is more organized and streamlined. For example, trials are conducted and trial data gathered PRIOR to admission for marketing approval. The data can also include what's been assimilated from the FDA trials.
EMA works with the company/developer to determine what trial data is likely needed for approval.
Centralized Authorization to market Afrezza basically means that it is approved to be sold in any European nation, which is better than doing it country-by-country. When Sanofi has the necessary trail data ready, they will apply for Centralized Authorization to market Afrezza and submit the data for review. The EMA has a maximum 210 days to complete the review, during which time they may ask for more information, if needed. When the reviewing committee is done, they forward their recommendation to the final approval committee. Final approval is about another 30 days.
Sanofi may have some ongoing Phase III trials designed specifically for improving the label (i.e. claiming superiority) or they may be completed and are waiting for other reasons. Regardless, there are two things that are relevant to me:
1. The EMA application gets published upon being submitted, and; 2. The EMA/EMEA review process does NOT have to run the full 210 days.
Afrezza delivers Human Insulin in a novel way, but this API has been proven safe for decades. After all, it's exactly the monomeric insulin that the human body produces. Meaning what? Meaning the Afrezza EMA review could be completed in a shorter timeframe than a unique API typically takes.
I suspect that the "delay" (so far it seems that Sanofi is not delaying, but is adhering to a predetermined schedule) may be due to trials using Sanofi's insulin...possibly even the Pfizer inventory that sits in cold-storage. I don't know.
Once the EMA application is submitted, things will start happening fast.
BTW - with digital advertising spanning the globe, if European advertisements tout Afrezza's PROVEN superiority over other RAA's, American physicians and consumers WILL take notice. It's also possible that the European trial data may be submitted to the FDA for label improvement as well. That would be a rather pleasant surprise for shareholders.
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Post by bradleysbest on Jul 2, 2015 13:01:20 GMT -5
Excellent stuff & appreciate the timely response! I am sure someone is checking their website & will post the application as soon as they see it! Hopefully we find out soon that SNY is working on this aspect.
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Post by babaoriley on Jul 2, 2015 13:27:44 GMT -5
Does anyone have an off the top of the head handle on getting approved in India - I hear that there are quite a few people there.
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Post by benh on Jul 2, 2015 14:01:04 GMT -5
India is a big fan of the inhaled medication. Huge population. Sanofi have large manufacturing there. Growing middle class/wealth. Big problem with diabetes and a Space program. (Delete as applicable).
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Post by _neil on Jul 2, 2015 15:17:34 GMT -5
India is a market where insurance coverage for drugs is non-existant. Even though the target population of diabetics is huge, they'll have a hard time converting any of that demand into actual sales due to the high cost of Afrezza. I think Sanofi will target the first world markets that can afford Afrezza before they go market it in India/China at discounted rates. Unless of course Sanofi pivots to a volume first, margins next approach which I doubt.
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Post by kball on Jul 2, 2015 15:53:08 GMT -5
Does anyone have an off the top of the head handle on getting approved in India - I hear that there are quite a few people there. Saw numbers of approx 60 million diabetics in india iirc. Slogan--try it, its not like its cow.
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Post by mnholdem on Jul 2, 2015 16:03:05 GMT -5
I did read about India, as well, but the only thing that I remember is that the agency responsible for approval may elect to waive the review process for drugs that have already been approved by the FDA. India is not a good country to start because they do not do a good job of protecting international patents. Lots of counterfeit drugs are made in India, or so I've read.
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Post by mannmade on Jul 2, 2015 16:10:53 GMT -5
I did read about India, as well, but the only thing that I remember is that the agency responsible for approval may elect to waive the review process for drugs that have already been approved by the FDA. India is not a good country to start because they do not do a good job of protecting international patent. Lots of counterfeit drugs are made in India, or so I've read. It is my understanding that along with all the patent protection TS applications are very complex and expensive to reproduce so as to make it tough for generic reproductions. I may be wrong but I believe Matt said this once upon a time. Also I read recently where Sanofi has "Sugar Clinics" in India for the specific purpose of treating diabetes so they have their own potential distribution chain to a certain extent.
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