With the intention to speed up novel uses of existing therapies, the FDA has opened up the STAR pilot program for applications. The basic idea of the program is to accelerate the review of certain products by splitting up the submission in two parts, allowing for the review to start before all the data is in.
To add a new indication to the labelling of an approved drug in the United States, a sponsor must obtain approval of a supplemental new drug application (sNDA) or supplemental biologics license application (sBLA).
Similar to the existing Real Time Oncology Review (RTOR) but applicable to supplements across all therapeutic areas, STAR aims to expedite access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. Applications reviewed under the STAR program will comprise two separate submissions.
STAR submission essentials
Part 1 should contain:
- All components of the supplemental NDA/BLA efficacy supplement, except for final clinical study reports for the adequate and well-controlled investigations supporting the proposed claim and the electronic common technical document (eCTD) module two clinical summaries.
- A document providing topline results for each of the adequate and well-controlled investigations, along with the applicant’s overall interpretation of the effectiveness and safety.
- Clinical protocol and amendments for pivotal trials
- Statistical analysis plan and statistical programs
- Tables, figures, and listings
- Death summaries
Part 1 will be submitted approximately 2 months, and no longer than 3 months, in advance of Part 2. The submission of Part 2 will initiate the PDUFA timeline.
Part 2 should contain:
- The clinical study reports for the adequate and well-controlled investigations (e.g., Phase III studies) intended to support the proposed indication, and the eCTD module two clinical summaries not included in the Part 1 submission.
STAR – how to do it
If your product may have additional indications and you consider that the efficacy supplement qualifies for review under the STAR program, you can request an informal pre-submission teleconference with FDA and provide FDA with topline trial results and proposed labelling. The preliminary discussion could also take place as part of a pre-sNDA/sBLA meeting.
If FDA agrees that the request meets the STAR program eligibility criteria, the application will be accepted, and you commit to providing the full application in two parts. The review will commence as long as the Part 1 submission is complete.
An application is eligible for STAR if each of the following criteria are met:
- Clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demonstrate substantial improvement on a clinically relevant endpoint(s) over available therapies.
- The application is for a drug intended to treat a serious condition with an unmet medical need.
- No aspect of the submission is likely to require a longer review time.
- There is no chemistry, manufacturing, or control information that would require a foreign manufacturing site inspection.
Breakthrough Therapy Designation (BTD) or Regenerative Medicine Advanced Therapy Designation (RMAT) is not required, but above criteria must be met.
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