Named Patient/Compassionate Use Programme
The serum sourcing and manufacturing status of AIMSPRO enabled granting, by the UK’s MHRA, of permission to import AIMSPRO as a “Special”, allowing 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. In addition to the disease categories mentioned earlier, 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. Daval supplies AIMSPRO to health care professionals for “named patients” for “compassionate use” purposes in the UK, Australia and New Zealand with enquiries and exports being undertaken to other countries, in full compliance with stated regulations. 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 continuous administration of AIMSPRO to patients, with well over 500 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.