Anavex Life Sciences Corp (AVXL)

[XenaLives]

Actually, the new pathway was only made available starting in March of this year, so only a few drugs have gotten provisional approval.

In March 2018, the TGA announced a provisional approval pathway. This will allow drugs to be available for up to six years based on preliminary data.9 The anticancer drug olaratumab is the first drug to be considered for provisional approval in Australia.

Access to new therapies is a balance between evidence (determining the risk of acceptable adverse effects versus efficacy) and the speed of availability, intersected by the issue of affordability. Making a drug available early with temporary authorisation is not a new concept, particularly for patients with life-threatening or seriously disabling conditions for which there is a clear unmet therapeutic need. Temporary access is akin to a learner driver receiving their provisional licence – a full licence is only granted after more experience. Rapidly approved drugs should receive provisional registration for a period of three years and the drug company should be required to provide annual data on the postmarketing experience.

In Australia at present, sponsor companies are required to report all negative outcomes that they become aware of, but there is no imperative for them to actively and meticulously seek out adverse events, or confirm efficacy after approval. As pharmacovigilance relies on spontaneous voluntary reporting of adverse effects by clinicians, it is highly likely that safety concerns are under-reported.

Improving the scientific rigor of postmarketing information to track effectiveness and safety outcomes, either through independently monitored registry studies as a condition of initial registration or data linkage (e.g. with linking of Pharmaceutical Benefits Scheme and Medicare Benefits Scheme datasets), will be of paramount importance during any provisional registration period. If efficacy outcomes in the real-world environment are not confirmed or a significant safety problem emerges, then the drug’s registration should be suspended, at least for previously untreated patients, until the sponsor satisfactorily addresses the problems.

https://www.nps.org.au/australian-prescriber/articles/fast-tracking-of-new-drugs-getting-the-balance-right

See also:
https://www.tga.gov.au/provisional-approval-pathway-prescription-medicines

The document with the table below has been posted before:



https://www.tga.gov.au/publication/provisional-determination

This drug was approved out of P2 in Austraila and by the FDA approval came on November second:

Pfizer Australia Pty Ltd
Designation/determination: Provisional approval Effective Date: 27/09/2018 Lapse Date: 27/03/2019
Medicine Name: lorlatinib

Therapeutic area: Oncology

https://www.tga.gov.au/ws-designation-notices-index