Enstilar submitted for psoriasis treatment in Europe

[Fred]

Following on from the report about Leo Pharma submitting their new aerosol for psoriasis to the FDA, today they announced they have also submitted a Marketing Authorisation Application to 30 European Health Authorities for Enstilar.

Quote:

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LEO Pharma today announced it submitted a Marketing Authorisation Application to 30 European Health Authorities for Enstilar (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) cutaneous foam for the treatment of psoriasis vulgaris, a chronic, inflammatory skin disease that can significantly impact quality of life for patients. Enstilar has the potential to be the first fixed combination cutaneous foam approved for the treatment of psoriasis vulgaris.

The new cutaneous foam formulation is a fixed combination of calcipotriol and betamethasone (as dipropionate) developed with the aim of improving treatment for patients with psoriasis vulgaris the most common form of psoriasis.

The European submission is based on the phase 3a trial, the PSO-FAST trial, which evaluated the efficacy, safety, itch relief and improvement of itch-related sleep loss across a four week period with Enstilar as well as the phase 2 maximum use systemic exposure safety study of Enstilar.

Kim Kjøller, Senior Vice President, Global Development at LEO Pharma, commented:

“We believe Enstilar has the potential to provide a new, topical treatment option for patients living with psoriasis. Helping people suffering from skin conditions is at the heart of what we do and this regulatory submission, along with our existing treatment portfolio and patient support offerings such as QualityCare, reinforces our commitment and takes another step toward improving quality of life for people living with psoriasis.”

Source: leo-pharma.com

LEO Pharma aerosol foam for psoriasis submitted to FDA

[jiml]

Following on from the report about Leo Pharma submitting their new aerosol for psoriasis to the FDA, today they announced they have also submitted a Marketing Authorisation Application to 30 European Health Authorities for Enstilar.

Quote:

---

LEO Pharma today announced it submitted a Marketing Authorisation Application to 30 European Health Authorities for Enstilar (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) cutaneous foam for the treatment of psoriasis vulgaris, a chronic, inflammatory skin disease that can significantly impact quality of life for patients. Enstilar has the potential to be the first fixed combination cutaneous foam approved for the treatment of psoriasis vulgaris.

The new cutaneous foam formulation is a fixed combination of calcipotriol and betamethasone (as dipropionate) developed with the aim of improving treatment for patients with psoriasis vulgaris the most common form of psoriasis.

The European submission is based on the phase 3a trial, the PSO-FAST trial, which evaluated the efficacy, safety, itch relief and improvement of itch-related sleep loss across a four week period with Enstilar as well as the phase 2 maximum use systemic exposure safety study of Enstilar.

Kim Kjøller, Senior Vice President, Global Development at LEO Pharma, commented:

“We believe Enstilar has the potential to provide a new, topical treatment option for patients living with psoriasis. Helping people suffering from skin conditions is at the heart of what we do and this regulatory submission, along with our existing treatment portfolio and patient support offerings such as QualityCare, reinforces our commitment and takes another step toward improving quality of life for people living with psoriasis.”

Source: leo-pharma.com

LEO Pharma aerosol foam for psoriasis submitted to FDA

I suppose this is good especially if it does relieve itching

[Caroline]

But if they did all kinds of research, why is it then that they "believe" that the product has potential?

[Fred]

But if they did all kinds of research, why is it then that they "believe" that the product has potential?

It's an English language thing.

[Caroline]

But if they did all kinds of research, why is it then that they "believe" that the product has potential?

It's an English language thing.

Ah, so it is not a belief like in God, the Pope or the FSM ?
It's pure being uncertain.

[Fred]

But if they did all kinds of research, why is it then that they "believe" that the product has potential?

It's an English language thing.

Ah, so  it is not a belief like in God, the Pope or the FSM ?
It's pure being uncertain.

More like "It Could Be" or "Could Possibly Be" or "There is a a good chance that it will be"

[Caroline]

But if they did all kinds of research, why is it then that they "believe" that the product has potential?

It's an English language thing.

Ah, so  it is not a belief like in God, the Pope or the FSM ?
It's pure being uncertain.

More like "It Could Be" or "Could Possibly Be" or "There is a a good chance that it will be"

Yes... Being uncertain comes close to that.

[Fred]

But if they did all kinds of research, why is it then that they "believe" that the product has potential?

It's an English language thing.

Ah, so  it is not a belief like in God, the Pope or the FSM ?
It's pure being uncertain.

More like "It Could Be" or "Could Possibly Be" or "There is a a good chance that it will be"

Yes... Being uncertain comes close to that.  

Maybe.