December 2022 in “International journal of drug regulatory affairs”
The US and EU lead in cell and gene therapy regulations with more approvals and clinical trials, while India is in early stages with fewer approvals and expedited processes.
Clascoterone's European release is expected in Q4 2026, with FDA approval anticipated by mid-2027. The discussion includes questions about the approval timeline and potential acceleration due to unmet needs.
Clascoterone in Winlevi, a topical AR antagonist, is being re-examined due to concerns about HPA axis suppression in adolescents, but it's unlikely to be banned for adult use in androgenetic alopecia (AGA). The European Medicines Agency recommended refusing Winlevi for acne vulgaris, but this may not affect Breezula's approval for AGA.
Topical finasteride in Europe is often seen as less effective than oral forms, with users suggesting alternative application methods for better results. Many prefer oral finasteride due to cost and effectiveness.
Be cautious when sourcing PP405 or its analogs from third-party suppliers due to potential safety risks and lack of regulatory approval. The conversation highlights concerns about counterfeit products and the absence of reliable testing, making it risky to use such treatments.
Topical dutasteride is more effective than finasteride for hair loss but lacks FDA approval and research, leading to less use. Users report varying effectiveness and side effects, with some preferring oral treatments.