Ann: Neurizon to Present Latest Results and Key Updates, page-95

The FDA will be very aware as you say, so that is a valued point. But it's not hard to find other examples of drugs that were approved after a phase 2.

Several drugs have been approved after phase 2 trials and gone on to be successful, particularly in oncology and infectious diseases. Here are some notable examples:

1. Vemurafenib: Approved in September 2011 for BRAF-mutated (V600E) melanoma, just 4 years after the first patient entered the phase I trial.

2. Crizotinib: Received accelerated approval in August 2011 for EML-4/ALK NSCLC, 3 years after the first patient entered the phase I trial.

3. Gleevec (imatinib mesylate): Approved under accelerated approval for chronic myeloid leukemia (CML) based on results from three large Phase 2 studies.

4. Mirvetuximab soravtansine: Received accelerated approval in November 2022 for platinum-resistant ovarian cancer based on a single-arm trial.

5. Lecanemab: While not yet fully approved, it has shown promising results in phase 3 trials for Alzheimer's disease, with significant reduction in clinical progression.

6. HIV drugs: Many drugs to treat HIV have been approved under accelerated approval provisions based on phase 2 results.
   

These examples demonstrate the success of accelerated approval pathways, particularly for drugs targeting specific molecular alterations or addressing unmet medical needs. The ability to gain approval based on phase 2 results, with confirmatory trials conducted post-approval, has allowed promising treatments to reach patients more quickly, especially in oncology and rare diseases.

Citations:

1. https://ascopubs.org/doi/10.14694/EdBook_AM.2012.32.114
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC9798349/
3. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-continued
4. https://www.fda.gov/media/102332/download
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC10593414/
6. https://clinicaltrials.gov
7. https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html
8. https://www.alzheimers.org.uk/blog/three-promising-drugs-for-treating-alzheimers-disease-bring-fresh-hope

Cheers