Skilarence (DMF) gets European Commission approval

[Fred]

A new dimethyl fumarate (DMF) treatment for psoriasis has been given European Commission approval.

Quote:

---

Almirall S.A. announced today that the European Commission (EC) has approved Skilarence®, a new oral formulation of dimethyl fumarate (DMF) developed by the pharmaceutical company, for the treatment for patients with moderate-to-severe chronic plaque Psoriasis. Skilarence® is to be indicated as a first-line induction and long-term maintenance treatment.

Almirall is due to start marketing Skilarence® in the third quarter of 2017 in all EU Member states, as well as in Iceland and Norway.

According to Eduardo Sanchiz, Almirall's CEO, "the EC's approval is very good news for healthcare professionals and for a large number of European patients, who will have access to a new therapeutic option for the systemic treatment of moderate-to-severe Psoriasis. Skilarence® is the result of Almirall's commitment to innovation, and making it available to doctors and their patients with Psoriasis will constitute a very important step in reinforcing the company's position as significant player in the field of Dermatology".

Skilarence® is the first fumaric acid ester (FAE) for the treatment of Psoriasis approved by the EC. Its approval in Europe is based on the positive results from the randomised, double-blind, placebo-controlled Phase III trial (BRIDGE), evaluating the efficacy and safety of this new oral formulation of dimethyl fumarate compared to Fumaderm®, presented in September 2016 at the prestigious 25th EADV Congress in Vienna (Austria). Published in the British Journal of Dermatology, the BRIDGE trial showed the non-inferiority of DMF compared to Fumaderm® and a good efficacy and safety profile.1

To date, a fixed combination of fumaric acid esters was only available in Germany in a different composition as well as locally compounded formulations in some countries like the Netherlands, Austria and some Nordic countries. The EC's decision will place this new oral formulation within the reach of all patients residing in all of the European countries.

Fumaric acid esters are a well-established oral systemic treatment for Psoriasis and are recommended in the European guidelines for both induction and long-term maintenance of the treatment of the disease. Long-term evidence coming from retrospective studies and registries highlights the clinical usefulness of the drug as well as its balanced safety profile.

About Skilarence® (dimethyl fumarate)

Skilarence®, dimethyl fumarate (DMF), is a type of fumaric acid ester (FAE), with anti-inflammatory and immune-modulating properties which is recommended in the European S3 Psoriasis guidelines for both induction and long-term treatment of adults with moderate-to-severe chronic plaque Psoriasis.2 A combination of FAEs is currently approved for the treatment of moderate-to-severe Psoriasis in Germany, with a positive risk-benefit profile for long-term use.3 DMF is considered the main active component in this combination.4,5 In fact, FAEs are the most frequently used first-line systemic Psoriasis treatment in Germany, with more than 20 years of an overall treatment experience that comprises of more than 180,000 patients.

Source: almirall.com

[jiml]

This is great news, I'm glad that Almiral have approval of a DMF drug....hopefully many other Europeans will be able to benefit from this treatment, DMF is a great drug and will be a great alternative to other first line treatments

[Caroline]

Truly great.
But I am very curious about the ingredients, the possibility of slow release and the possibility of enteric coverage in order to protect your stomach.

Also curious about the price. , can it compete with Bill's version......

We will hear more of it in the future.

[Bill]

Too right, Caroline. From what I read on the NICE site it will be 1500 pounds a year cf about $2 US a year for the air freighted raw stuff that I recently bought. And now that my supply worries are over I can indulge in a little more experimentation. I find the idea of a slow release formula for DMF a flawed idea on many levels. What I have tried most recently is micronised DMF, or in other words I put some DMF in a blender and turned it into a fine powder not unlike icing sugar. In this form DMF can disperse easily in a liquid, so dosing for me is now simple and not unpleasant. As DMF is a contact irritant, a fine and well dispersed powder should reduce any gastric irritation. I have found this to be the case for DMF taken this way, as well as it being more rapidly absorbed: This ensures that any irritation is in the upper part of the gastric tract, so there is no chance of diarrhoea.

Cheers,

Bill

[artemie]

Good news! About time. Also, that's interesting, Bill. For me (and I think for Caroline too) the only doable DMF was enteric coated and slow release. Because of less stomach/bowel irritation and pains. Storing this for future reference, maybe I can go back on the DMF one day.

[Turnedlight]

Bill with all the reasearch you've done I would think you could open your own lab and produce a great product!

I'm glad there's another drug in the armoury that I haven't tried yet. I have a sneaking suspicion I won't get on with the stomach problems though..

[jiml]

Bill with all the reasearch you've done I would think you could open your own lab and produce a great product!

I'm glad there's another drug in the armoury that I haven't tried yet. I have a sneaking suspicion I won't get on with the stomach problems though..

Ahhh but the stomach problems don't last long TL and if skilarence is pure DMF the side effects could be less, possibly similar to Psorinovo

[JohnB]

Well from personal experience this week it won't matter for me unless it's only a couple of coppers a throw. £1500pa still means that I have to fail mtx and cyclosporine or go back on to Acitretin. It's looking like Fumaderm would be a no go coz it costs more per annum than a nurse (quote). So I guess bio's are out.
I just hope and prey that someone gets their act together and markets this at a sensible price then it can become first line treatment

[jiml]

Well from personal experience this week it won't matter for me unless it's only a couple of coppers a throw. £1500pa still means that I have to fail mtx and cyclosporine or go back on to Acitretin. It's looking like Fumaderm would be a no go coz it costs more per annum than a nurse (quote). So I guess bio's are out.
I just hope and prey that someone gets their act together and markets this at a sensible price then it can become first line treatment

I don't know where the cost of 1500pa comes from but that's  only just over £28 a week I think that's in line with other treatments John .....I'm not sure how much  or Methotrexate costs ...but I doubt it will be much less than that....but I could be wrong  

[Fred]

Well from personal experience this week it won't matter for me unless it's only a couple of coppers a throw. £1500pa still means that I have to fail mtx and cyclosporine or go back on to Acitretin. It's looking like Fumaderm would be a no go coz it costs more per annum than a nurse (quote). So I guess bio's are out.
I just hope and prey that someone gets their act together and markets this at a sensible price then it can become first line treatment

I don't know where the cost of 1500pa comes from but that's  only just over £28 a week I think that's in line with other treatments John .....I'm not sure how much  or Methotrexate costs ...but I doubt it will be much less than that....but I could be wrong  

I'm not sure where Bill got the figure but I have found these.

Methotrexate 2.5mg tablets Qty 28 Price  £172

Ciclosporin 25mg capsules Qty 30 Price £1837

Acitretin 10mg capsules Qty 60 Price £2380

I don't know how much that would work out per year, but it's the cost to the NHS as far as I can work out.