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.
Law 648/96 allows innovative new treatments to be prescribed for patients with no other effective therapy if they have been approved by other regulatory agencies, are already successful treatments ‘off-label’ or are still undergoing late stage clinical trials.
Since 1996, thirty-six treatments have been made available for the treatment of previously unaddressed conditions. Today the afamelanotide implant joins this list as the first treatment which is still under clinical review in Europe.
Significantly, inclusion in the list also allows the cost to the patient of the treatment to be reimbursed by Italy’s national health system, the Sistema Sanitario Nazionale (SSN).
The technical and scientific committee, or Commissione Consultiva Technico Scientifica (CTS) reviewed existing data on afamelanotide’s safety and efficacy and subsequently issued approval for inclusion in the national programme.
This listing is the result of an application put to the Italian Medicines Agency (AIFA) by physicians and specialists as a response to continued requests from the population of Italian EPP patients to access afamelanotide after the completion of clinical trials. While Clinuvel has supported a 12-month compassionate use program in Italy at the end of the CUV017 study, a further continuation would have proven prohibitively expensive for the company. Further demand for afamelanotide instigated AIFA to review the pharmacological and technological properties of afamelanotide and, following assessment of the safety and benefits to patients, AIFA took the decision to include afamelanotide on the list of reimbursable drugs.
Clinuvel is excited and in a proud position to be able to provide treatment to these patients while we finalise the clinical program for EPP globally. In the meantime, the scientific teams at Clinuvel continue the development of a pediatric formulation to assist juvenile EPP patients.
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Congrats Clinuvel
Here’s hoping that Clinuvel can emulate Cochlear in establishing a worldwide brand. Obviously exciting for the patients who need the treatment as well.