Afamelanotide (Scenesse) now available in Italy

afamelanotide

Clinuvel has announced today that Italy has pre-empted the approval of Afamelanotide by the FDA in the US by approving it for the treatment of erythropoietic protoporphyria (EPP).

Despite the relatively small number of participants in the Italian trial to treat EPP, and the small number of EPP sufferers thought to directly benefit from this therapy, the approval by Italian Medicines Agency (AIFA) is significant because it confirms Afamelanotide’s efficacy and safety and also that national medicine agencies are willing to rapidly approve afamelanotide.

This announcement represents one more small step towards the approval of afamelanotide worldwide as a treatment for the conditions chosen by Clinuvel, namely; Erythropoietic Protoporphyria, Actinic Keratosis and Squamous Cell Carcinoma in Organ Transplant Recipients, Polymorphic Light Eruption, and Solar Urticaria.

Despite not being currently targeted as rosacea treatment, Afamelanotide remains interesting for rosacea sufferers who identify exposure to the sun as a significant trigger for their symptoms.

Unexpected news for afamelanotide from Italy

An unprecedented and unexpected announcement over the weekend has lead to the company’s announcement this morning that afamelanotide will be first made available to Italian erythropoietic protoporphyria (EPP) patients prior to its formal approval anywhere else in the world.

A governmental publication in Italy has confirmed that Clinuvel’s afamelanotide implant formulation can now be prescribed for patients diagnosed with EPP under Law 648/96, while marketing authorisation for the European Community is being prepared.

and from;

Italian Medicines Agency (AIFA) provides reimbursement for the treatment of EPP with afamelanotide

Through inclusion in the 648/96 list, afamelanotide can now be prescribed on an individual basis to adult patients diagnosed with EPP. Beneficiaries may be either former participants in clinical studies (CUV017) or other patients who are positively diagnosed with EPP.

Although the exact prevalence of EPP in Italy is unknown, it is estimated that approximately 60 patients will initially benefit from this treatment. Afamelanotide’s inclusion on the 648/96 list has been formally announced by Italian legislators, allowing the drug to be prescribed to patients with immediate effect.

[update:] Clinuvel have also announced that afamelanotide will be marketed under the brand name of Scenesse (pronounced “sen-esse”). From today onwards, Clinuvel will adopt SCENESSE in all references to the drug in its further global clinical development.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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11 Reader Comments

  1. max says:

    About time. Can’t wait to go there and try this wonder drug!!!!! Come US already!!!

  2. David Pascoe says:

    One would be tempted to say that Italy approving Scenesse will help the FDA confidently approve it also.

  3. felipe says:

    David , so if i go to italy can i obtain Scennese????????

  4. David Pascoe says:

    He Felipe,

    If you are eligible for government subsidized pharmaceuticals in Italy and find a doctor who will prescribe it for your EPP, then you can obtain it in Italy.

    It is thought that about 60 people are in this category, so the numbers are small, but the potential good news for other sufferers is encouraging.

    davidp.

  5. john Clark says:

    Hi Just wondering if anyone who is rrecieving treatment in Italy has spoken of its effectiveness??

  6. mike s says:

    Will someone please direct us (vit. patients) to a dermatologist in italy that will treat us with scenesse.

    Thank you very kindly

    Mike

  7. David Pascoe says:

    I don’t know how to team you up with a particular dermatologist in Italy, sorry – but Clinuvel has submitted Scenesse for approval in Europe. Hopefully in a few months time it will become widely available in Europe.

  8. Fred Rixburg says:

    I have suffered with Vitaligo for about a year now and is my understanding that Scenesse and narrowband will help my disease. Has anyone heard anything to this affect?

  9. David Pascoe says:

    Hi Fred,

    It is still very early days for trialing Scensse and Vitiligo. The hope is that Scenesse will be able to help with the treatment by stimulating the melanocytes and having more available to help with re-pigmentation. This is still on the distant radar for Clinuvel, only very early discussions are taking place, trials to come in the future.

    dp.

  10. Jill says:

    How do I get this?

  11. nora says:

    Pleaseee….does anyone have a name and adress of a dermatologist in italy.i suffer from vitiligo…maybe they can help by now??

    nora

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