Research & Development
 

Named Patient/Compassionate Use Programme

AIMSPRO® has been granted permission, by the UK’s MHRA, to import AIMSPRO® as a “Special”. This allows the drug to be prescribed by UK doctors on a named patient basis to treat patients for “unmet medical needs”. It is also available in Australia under Categories A and B of the TGA’s Special Access Scheme.

Daval has recorded that AIMSPRO® has been used to treat patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Parkinson’s disease, neuropathic pain, Adhesive Arachnoiditis, Myasthenia Gravis, Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis), Psoriatic Arthritis, Osteoporosis, Ankylosing Spondylitis, Juvenile Arthritis, Dercum’s Disease, chronic venous ulceration, HIV and Hepatitis C.

In support of its “named patient programme” Daval has signed a global access pre-approval distribution contract with UK-based Idis Limited, a specialist in named patient programmes. Idis is expert at meeting the import requirements of a vast range of jurisdictions and will manage all non-UK requests for the supply of AIMSPRO® to physicians, hospitals and pharmacies until Marketing Authorisation is achieved.For health care professionals seeking further information about being able to participate in the named patient programme in the UK please contact Daval at: npp@davalinternational.com

For all enquiries about being able to participate in the named patient programme outside of the UK please contact Idis directly via telephone at +44(01)1952 824 100, fax +44 (0)1932 824 300, or via email at customerservices@idispharma.com.

It should be noted that despite the apparent promise of AIMSPRO®, it is still under investigation and its long-term safety in a large population of patients has not been fully established and the potential risks of the drug have not yet been totally identified. However, in all the years of administration of AIMSPRO®, with over 600 patients having received the drug, no medication related serious adverse events have ever been reported and no “Yellow Cards” (the mechanism for enabling the halting of the provision or administration of a drug due to a reported serious adverse event or serious side effect) have ever been recorded by the MHRA.

There has been no event, regulatory intervention or clinical observation which might present an impediment to further commercialisation of AIMSPRO®.