Secukinumab gets one step closer to approval in Europe for treating psoriasis.

[Fred]

Following on from other reports recently about Secukinumab showing good results when up against Enbrel, Novartis have announced it has received positive opinion recommending approval from the Committee for Medicinal Products for Human Use (CHMP) for a first line treatment of moderate-to-severe plaque psoriasis in adults.

Quote:

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Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Cosentyx™ (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

This recommendation would mean doctors could use secukinumab first-line to treat their psoriasis patients, as an alternative to other first-line systemic treatments, which have significant side effects. Currently, all biologic treatments for psoriasis, including anti- tumor necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy in Europe.

Secukinumab (at a dose of 300 mg) is the first interleukin-17A (IL-17A) inhibitor to be recommended as a first-line treatment option for psoriasis patients who require systemic therapy in Europe. Secukinumab works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by the disease.

"This positive CHMP opinion for secukinumab as a first-line treatment of psoriasis brings us one step closer to approval in Europe and making clear skin a reality for psoriasis patients," said David Epstein, Division Head, Novartis Pharmaceuticals. "With this exciting news, we may change the way psoriasis is treated, as 50% of patients are unhappy with their current psoriasis therapies, demonstrating an urgent need for new treatments that clear skin faster and for a longer time."

The ultimate aim of psoriasis treatment is clear skin for patients. In clinical studies, 70% or more patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) with secukinumab 300 mg during the first 16 weeks of treatment.

The CHMP opinion was based on the positive results of the Phase III clinical trial program in moderate-to-severe plaque psoriasis and follows the unanimous recommendation of approval in October from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA).

The European Commission reviews the recommendations of the CHMP. The final decision on approval, usually granted in approximately two months of the CHMP opinion, will be applicable to all European Union (EU) and European Economic Area (EEA) countries.

Source: novartis.com

Follow the story on Secukinumab here:

Secukinumab V Enbrel
Secukinumab V Stelara
Novartis AIN457 (secukinumab) data shows relief for 81% of psoriasis patients
Secukinumab efficacy and safety report

[jiml]

Just a small question reading the text they talk of first line systemic treatment and second line systemic treatment .
What does that mean in laymen's terms?

Looks like more good news for the future costs allowing ..............

[Fred]

Just a small question reading the text they talk of first line systemic treatment and second line systemic treatment .
What does that mean in laymen's terms?

Looks like more good news for the future costs allowing ..............

Where's Matari when you need him.

I'll take a guess and say, they are suggesting instead of trying Remicade or Enbrel first it would be a good idea to try Secukinumab first.

But don't quote me on that.

[Caroline]

Just a small question reading the text they talk of first line systemic treatment and second line systemic treatment .
What does that mean in laymen's terms?

Looks like more good news for the future costs allowing ..............

Where's Matari when you need him.

I'll take a guess and say, they are suggesting instead of trying Remicade or Enbrel first it would be a good idea to try Secukinumab first.

But don't quote me on that.

I always thought that it is the first choice they will make.
So... You got psoriasis, you need systemic, ok here we gonna try blablamab first.
Like it previously would be MTX first, that is now shifting to payable biologicals (or DMF), then if those do not work, they shift to the more expensive and slightly different working dadaMAB's as the second line.

So there is progress. Slowly they begin to skip the medications that only make you sicker.

[jiml]

Just a small question reading the text they talk of first line systemic treatment and second line systemic treatment .
What does that mean in laymen's terms?

Looks like more good news for the future costs allowing ..............

Where's Matari when you need him.

I'll take a guess and say, they are suggesting instead of trying Remicade or Enbrel first it would be a good idea to try Secukinumab first.

But don't quote me on that.

I always thought that it is the first choice they will make.
So... You got psoriasis, you need systemic, ok here we gonna try blablamab first.
Like it previously would be MTX first, that is now shifting to payable biologicals (or DMF), then if those do not work, they shift to the more expensive and slightly different working dadaMAB's as the second line.

So there is progress. Slowly they begin to skip the medications that only make you sicker.

Thanks caroline it makes good sense and if a MAB is going to be frontline rather than methopoison well I'm all for it ...
We just have to get DMF more accepted ... It will happen

[Caroline]

But now it is interesting and bad news for our friends with MS.
Previously there was a medication Lemtrada, or alemtuzumab, which was working against leukemia.
It was removed from the market in 2012.
Now recently it has been set back into the market, because it also appears to slow down the progress of MS, exactly the same product, for a price ................... 40 times more expensive.

[jiml]

But now it is interesting and bad news for our friends with MS.
Previously there was a medication Lemtrada, or alemtuzumab, which was working against leukemia.
It was removed from the market in 2012.
Now recently it has been set back into the market, because it also appears to slow down the progress of MS, exactly the same product, for a price ................... 40 times more expensive.

Are we being ripped off by the big pharma companies ........ Yes most definitely .....shame on them .... Reinstating a product at vastly inflated prices......., and why...... Because they can

[Fred]

Are we being ripped off by the big pharma companies ........ Yes most definitely .....shame on them .... Reinstating a product at vastly inflated prices......., and why...... Because they can

So like I always say. "Vote with your feet" You don't have to use their product, it's your body and you own it. So choose what you feel is worth it, or what you feel is working for you. We all have a choice, I would never take methotrexate again but not because of cost.

I'm happy as I have also said with Stelara, but if I had to pay for it then; No I would have to find an alternative.

A lot of people seem hung up on the cost of treatments, but I think it's available, I've paid my dues, it works, so I'll take it thank you.

[jiml]

Are we being ripped off by the big pharma companies ........ Yes most definitely .....shame on them .... Reinstating a product at vastly inflated prices......., and why...... Because they can

So like I always say. "Vote with your feet" You don't have to use their product, it's your body and you own it. So choose what you feel is worth it, or what you feel is working for you. We all have a choice, I would never take methotrexate again but not because of cost.

I'm happy as I have also said with Stelara, but if I had to pay for it then; No I would have to find an alternative.

A lot of people seem hung up on the cost of treatments, but I think it's available, I've paid my dues, it works, so I'll take it thank you.

It's not always a choice people have to vote with their feet in the UK you take what you are offered ..... Yes you can protest and ask for something else.... But if it's to expensive for the health service or in other countries insurance companies .. The drug won't be prescribed except in exceptional circumstances.... I think the reason I'm hung up on the cost of treatments is not because mine is expensive because it's not .... It's because I have seen several cases on here where treatments have been denied members purely on the grounds of cost..... And I feel that is so wrong ..... Not many can afford to pay full price for their treatment and even with help from the manufacturers they still have to find a fair amount of money .... Which isn't always available
Jim falls off soap box with red face

[Fred]

It's not always a choice people have to vote with their feet in the UK you take what you are offered ..... Yes you can protest and ask for something else.... But if it's to expensive for the health service or in other countries insurance companies .. The drug won't be prescribed except in exceptional circumstances.... I think the reason I'm hung up on the cost of treatments is not because mine is expensive because it's not .... It's because I have seen several cases on here where treatments have been denied members purely on the grounds of cost..... And I feel that is so wrong ..... Not many can afford to pay full price for their treatment and even with help from the manufacturers they still have to find a fair amount of money .... Which isn't always available
Jim falls off soap box with red face

Fred gets back on his soap box and although we are taking this thread off topic.

Ladies and Gentlemen, you all have a choice. Yes I appreciate in some countries it may come down to what you can afford, but what I know of it in most countries there is some form of subsidised or free treatment. If there is not then I do genuinely feel sorry for those people, but that is life and that is our lot so to speak. We can not change the world or politics when it comes to medical treatment, and who are we to even say that a country is wrong to not allow a treatment. At the end of the day it's up to that country and it's voters that decide.

So it brings me back to "Vote with your feet" if you don't like the way it is then either don't use it or make your voice heard and push your government to negotiate a lower price.

Jim you live in the UK and you have a vote, all treatment that is available under your governments health system is available for all. So to say not many can afford to pay, does not apply in your case. You pay your NHS charges and get your medication, why should you care how much it costs.

Fred thinks he should now step off his soap box, as this could end up becoming a heated debate about the health care of individual countries where as in fact the thread is about a new treatment for psoriasis.

Over to you Jim or anyone else, I promise not to respond.

Apart from I may have spelt heard as in to hear wrong, or even here................... Oh I don't know.

I do like a good debate though.

I'm done.