The potential for medicine repurposing is on the rise as an increasing number of products are being registered on the Australian Register of Therapeutic Goods (ARTG) for therapeutic claims beyond their original purpose.
Where a medicine has been marketed between 5 and 10 years in Australia, or a highly regarded global region such as UK, Sweden, Netherlands, USA, New Zealand and Canada, a new therapeutic claim may be possible via a Literature Based Submission (LBS). The LBS pathway allows a registration to rely on high quality scientific literature evidence sourced from various reputable databases, rather than the clinical trial pathway, which presents significantly higher financial and time-to-market burdens.
It is time to give old products new life by considering the available data for potential new indications.
The Therapeutic Goods Administration (TGA) pre-submission guidance outlines the requirements for both the search strategy and the systematic review of all the literature outputs. The search strategy, including the databases to be searched and the criteria for search results are tightly regulated and full of complexities to ensure no ‘cherry picking’ of optimal data. For prescription medicines, the strategy is to be approved by the TGA prior to submission. This process ensures the search strategy is well designed and that the review minimises any selection bias. The process is a highly complex landscape that relies on a comprehensive understanding of how to extrapolate different formulations and dosage forms to your targeted population from 1000’s of search results.
How can Commercial Eyes help?
At Commercial Eyes, we specialise in helping medicines find new purposes to benefit the right patient populations. With 8-10 successful Literature Based Submissions (LBS) completed every year, our team has the expertise to ensure your LBS search strategy is effective and efficient.
If you’re interested in developing your LBS search strategy and need support, please contact our experienced team at [email protected].
For more information, please contact us at [email protected].
Maria Dionyssopoulos
Head of Regulatory, Quality and Compliance
Maria has extensive experience in developing regulatory strategies and providing insightful regulatory advice to a variety of...
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