Date:11 April, 2013

News from Alpha 1 Alliance on Grifols and future of UK Prolastin

We have received the following press-release today from the Alpha-1 Alliance (of which the Alpha 1 Awareness UK charity is a part). The statement says:

Alpha-1 Alliance update – Future of augmentation therapy in the UK

The Alpha-1 Alliance is campaigning for the establishment of a highly specialised service for Alpha-1 patients within the NHS in England.  A crucial element of a new service will be access to augmentation therapy for patients who meet set clinical eligibility criteria.

In exceptional circumstances, patients can be treated with unlicensed medicines.  However, in order to secure access to augmentation therapy routinely as part of a highly specialised service, a licensed therapy will need to be made available.

Grifols, the Spanish manufacturer of augmentation therapy Prolastin, has recently communicated to the Alpha-1 Alliance that they do not currently intend to seek a license for Prolastin in the UK.  Our understanding is that due to regulatory complications Grifols will not be taking forward a license application at the present time.  While this is extremely disappointing news, the Alpha-1 Alliance is grateful to Grifols for the support they have shown towards the campaign and the Alpha-1 community in the UK.

The Alpha-1 Alliance has started the process of formally engaging with manufacturers of similar augmentation therapy products in order to ensure that a treatment is made available in the UK.  All members of the Alpha-1 Alliance (including the Secretariat) remain wholly committed to taking forward the campaign for a highly specialised service with access to augmentation therapy, and we are confident that this can be achieved.