Enstilar gets EU approval

[Fred]

Following on from this report Enstilar submitted for psoriasis treatment in Europe Leo Pharma annouced today it has received approval for Enstilar in Europe for patients with psoriasis.

Quote:

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LEO Pharma today announced that it received scientific approval of Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g)  for the treatment of psoriasis vulgaris in patients 18 years of age or older. Enstilar® is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.  

“The scientific approval of Enstilar® is exciting news, not only for LEO Pharma but also for the millions of Europeans living with psoriasis,” said Gitte Aabo, President and CEO of LEO Pharma.  “Enstilar® is a first-of-its-kind topical spray foam and we believe it will help people living with psoriasis by providing a new type of treatment option that they are looking for.”

Enstilar® was developed to treat patients with psoriasis vulgaris, the most common clinical form of psoriasis. In Europe, nearly four million people are living with psoriasis.

The application in the EU decentralized procedure for Enstilar® was based on the pivotal Phase 3a PSO-FAST study which evaluated the efficacy and safety profile across a four week period, and the Phase 2 MUSE safety profile study.  In the PSO-FAST clinical trial, over half of patients treated with Enstilar® were “Clear” or “Almost Clear” by Week 4 as measured by the Investigator Global Assessment (IGA) improvement score.1 Additionally, more than half of patients treated with Enstilar® achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.

The scientific approval means that LEO Pharma has received a positive outcome of the decentralized procedure.  Receiving this positive outcome is the final step before national marketing authorisations can be granted by the 30 EU countries which are part of the procedure.  The national approvals of Enstilar® are expected later this year.  In October 2015, Enstilar® was approved for use by the U.S. Food and Drug Administration (FDA).  

Source: leo-pharma.com

[jiml]

More good news for the Europeans according to Mataribot the spray is quite effective. So it will be nice that the dermatologists have another treatment to offer as its a new way to apply this treatment, I wonder what the cost will be and whether NICE will approve it for the UK

[Fred]

More good news for the Europeans    according to Mataribot the spray is quite effective. So it will be nice that the dermatologists have another treatment to offer as its a new way to apply this treatment, I wonder what the cost will be and whether NICE will approve it for the UK

I think Matari said it was very expensive, but then new things always are at first. But the cost won't be prohibitive for most Europeans as they will get it under their health system.

As for if the UK will get it, we will have to wait and see. They did negotiate a deal for Stelara I think it was, so they may do the same with other new treatments.

As for here in France. By the time they get all the paperwork finished to prescribe it, it will probably be an old treatment.

[mataribot]

The only thing really new about this drug is the delivery method. I am guessing a more uniform application leads to better results. While I like this product, I don't see how it's justifiable with it's current price tag.

[Turnedlight]

Sounds a bit like bettamousse which makes it easier to get betnovate on the scalp. Trouble is, given the choice the docs will just want to give us the cream which is cheaper. I'd like to try some though.

[AmandaL]

I'm going to ask my dermatologist tomorrow if they have this and give it a try.

[Fred]

I'm going to ask my dermatologist tomorrow if they have this and give it a try.

Please do start a new thread about your experience if you get it.