phase 2 release of data expected sept 15, Pfizer will start phase 3 in 2019.  

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Hi Nor75,

I agree alopecia is not a disease to be accepted! I think Europe and UK consultants just say that so there would be no pressure on paying for a treatment and these rubbish con companies can continue to make money! It's a joke! 

I know Alopecia UK are now aware of it and are pushing for alopecia to be known as a disease rather than a cosmetic condition.

Europe and UK il feel will be the very last to approve anything for alopecia its sad to say :(.

Hi Kim, 

Thank you for the information. Although it is great a product has finally got to phase 3 with others to follow

If your estimates are right then that's 3.5 years for a product to get approved in the US and about 4.5/5 years to get approved in UK and Europe as they are miles behind as usual.

My advice to people would be if you had alopecia along time then act now and try get it off label under a supervised Dr as prolonging it even more can't be good.

And yes these wigs companies and shampoos and other bogus companies be phased out soon as with everything has a sell by date and with science and technology updating hopefully these companies will become extinct lol.

But they still have like a few years from what Kim is saying on approval dates. 

Do you think these drugs will be available “off label” ? Would a doctor in the US be able to subscribe them to a European patient before 2021/2022 ? 

Hi Bibby, 

These new drugs like ctp-543 and pf-06651600 will not be available off-label as these are new compounds and to be made available for off-label use they will likely need to be approved for another condition. For example xeljanz ( tofacitinib) is approved for rheumatoid arthritis hence why people get it off-label for alopecia. 

That is just my personal view on it. 

Hope that helps mate.

I think the biggest problem is that most countries that have social health care won't approve these kind of drugs because the government doesn't want to pay for it because of the extremely high cost. 

For example, even tho Xeljanz is approved in Canada solely for RA, a Rhuematologist can't prescribe it to a patient outright before the patient is first put on cheaper traditional meds like Methotrexate, Prednisone, etc for at least a year and shows no improvement or some kind of reaction/side effect.   

Let's hope that the Pharma companies price these 3rd gen meds biologics "for alopecia" more reasonably than they have in the past for RA. 

Hi TC,

That is a very good point! I feel governments should put some sort of sanctions or laws in where these pharmaceutical companies can't over price there products! The more difficult part is that if there were sanctions put in place then would the urgency to develop 3rd generation drugs slow the demand.

If only there were charitable pharmaceutical companies out there.

Hi Singh,

I don't think Pharma needs to be charitable, per say. But I think we can all agree that expecting people to pay $3,000-5,000/month for a medication is insane. It needs to be reasonably affordable for governments to be willing to approve it for what they believe is a "cosmetic" illness.

So Pharma has 2 choices.

Price it outrageously and be limited to a small volume of sales in US, and maybe a few other countries to recoup their R&D. Or price it more reasonably and reap the global sales benefit of greater volume. Naturally, we hope they choose the later.

 

  

Hi TC, 

Agreed! Either way they would still make billions! But i still feel they need to be pressured a bit to achieve the later..

It's strange and unfair the way people in the US pay at least $4000 for a box of xeljanz. But in Turkey or Mexico it is about $800.

It’s about $550-$600 a box in turkey , it’s crazy stuff 

Hi Kim! Thanks for posting this. Do you think these drugs will be available for children diagnosed with AA? If so, do you know anything about the age at which they can start? My daughter has AU. 

I am going to post objective info on children on a new post. 

Interesting is also that Pfizer dropped PF-06700841, for AA although it was the more effective one, but will continue the drug in Psoriasis. Says everything you need to know what people think about AA... "just cosmetic".

(NO, IT IS NOT JUST COSMETIC.. it is completely disfiguring and eyes without lashes are full of dirt at any given time and a nose without hairs is permanently infected... When do they get that?)

But, that means there are effectively only ATI 501, CTP 543 and PF 06651600 left.

Ok, there is LY 3009104 (who wants to get trombiosis) and RVT 502 (I guess that is rather promotion for the brand). Ok, and also BNZ-1. But whether it will ever kick-off is completely open.

Chances for CTP 543 are distressed as there is Incyte preparing to destroy it with their patent claim.

I sense somehow that Pfizer will not bring  PF-06700841 to the market. They have said for many years, they do not want to deal with AA whatsoever...

At the end there will be only ATI 501 left in the run. And that said, if there is anything happening in the trials with ATI 501 they will dump it.

And the topical JAK inhibitors have recently proven to be only as good as Bethametasone Foam (btw why is that not available anywhere anymore??)

Guys, I think it is rather not looking good...

People in the US will continue with Xeljanz off-label and depending on the good will of insurers - until something goes seriously wrong as it is a PAN-JAK, and then no insurer will approve it anymore, and people in Europe will not get anything.

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