TGA Application Lodged for SKYCLARYS®

You will be aware that we have been in regular communication with Biogen regarding FA treatment SKYCLARYS® .

We are delighted to be able to advise that Biogen Australia has confirmed that they have lodged a regulatory application for SKYCLARYS® with the Australian Therapeutic Goods Administration. This took place in July however was only made public today by the Federal Government Department of Health & Aged Care.

The Regulatory & Reimbursement process in Australia is a multi-stage undertaking. This initial stage is, broadly speaking, an analysis of data on SKYCLARYS®
 
Should an indication of acceptance by the Therapeutic Goods Administration be received by Biogen, the next critical phase becomes Pharmaceutical Benefits Advisory Committee review.

For further information on this process, click here to see Biogen's presentation from our February Patient Information Forum.