Anavex Life Sciences Corp (AVXL)

[attilathehunt]

I got a reply from the TGA:


Here is my note to them...

I understand the TGA recently gave compassionate SAS approval to use Blarcamesine (please see attached ).

https://www.anavex.com/anavex-life-sciences-receives-tga-special-access-scheme-approval-for-anavex2-73-blarcamesine-for-alzheimers-disease-patients/

Is compassionate use for those currently in the trial or can my Uncle’s doctor request it? In other words, can non-trial participants be eligible for compassionate use if their doctor agrees?

Thank you for responding.

Regards,

Scott

Here is their reply...
Dear Scott
Thank you for your enquiry of 10/08/2020 to the Therapeutic Goods Administration (TGA).
Unless exempt or otherwise authorised by the TGA, therapeutic goods lawfully supplied in Australia must appear as an entry in the Australian Register of Therapeutic Goods (ARTG).
There are situations where special policies have been developed in response to the needs of particular people or circumstances. These policies have resulted in certain therapeutic goods being available without the need to be entered onto the ARTG. Information on some of these policies and the relevant procedures can be found at:
Special Access Scheme
Authorised prescribers
Personal import scheme
Clinical trials exemption scheme

The Special Access Scheme (SAS) allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) for a single patient. Therapeutic goods that are not included in the ARTG (and are not otherwise exempt from being in the ARTG) are described by us as 'unapproved'.
Please speak to your Uncle's health professional about accessing Blarcamesine through the SAS for him.
If the publicly available information above does not address your query, please contact the sponsor of the therapeutic goods or consult your health professional regarding:
· availability of, or access to, goods
· manufacturing location or process
· ingredients or contents
· advice on using the good
· suitable alternatives to the good.

For more information about the TGA, please refer to the short video on the Role of the TGA.
Yours sincerely
Rebecca

Regulatory Assistance Service
Regulatory Guidance, Assistance and SME Section

Regulatory Engagement, Education and Planning Branch

Phone: [phone] Fax: [phone]
Email: [e-mail]

Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia