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R&D Trends: Psoriasis - Pipeline outlook following withdrawal of key regulatory filing
Datamonitor, March 2011, Pages: 65
Introduction
128 products in development have been identified, with a notable focus on interleukin (IL) targets. 2009 market entrant Stelara, an IL-12/23 inhibitor is fuelling interest in IL therapies. Stelara (ustekinumab) and briakinumab showed benefit over established brand Enbrel (etanercept) in head-to-head trials, augmenting physician view that future trials require more active comparators.
Features and benefits
- Enhance understanding of the competitive landscape and potential future market dynamics with an in depth analysis of the psoriasis pipeline
- Benchmark novel and existing therapies using the ideal target product profiles identified by Datamonitor and access leading dermatologist opinion
- Support R&D decision making by evaluating psoriasis clinical trial designs that have set a precedent, as well as analysis of discontinued projects
Highlights
- Interleukins are key targets for late and early-stage programs. If IL selectivity leads to better efficacy and safety, new drugs would gain backing from physicians. However, cardiac risks may be an issue, as shown by briakinumab. In the current risk-adverse regulatory environment clinical trial designers should consider how to dispel these fears.
- The Psoriasis Area and Severity Index (PASI) remains the gold standard tool for efficacy, due to historic use and ease of benchmarking new and existing therapies. Phase III trials like Stelara versus Enbrel lead dermatologists to speculate that regulatory agencies will desire analyses from direct comparator trials in future drug approval.
- Drug attrition rates are high in psoriasis, with a mix of commercial and clinical reasons behind this. Established brands and generics seems to deter companies from pursuing some topical agents, while the higher dose of biologics often required to show meaningful efficacy in psoriasis compared to say rheumatoid arthritis creates further challenges.
Your key questions answered
- What do key opinion leaders think is the ideal target product profile in psoriasis?
- Which innovative therapeutic approaches do leading dermatologists believe are the most promising for small molecules and biologics?
- How will biomarkers and comorbidities play a role in the future treatment of psoriasis?
- What is the breakdown by delivery methods for candidates being developed for this chronic skin disorder?
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