Kinesys Consulting last month secured another PIM designation, this time for a new oncology product, on behalf of a US partner. The product, successfully designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA), is being developed for the treatment of cutaneous T-cell lymphoma (CTCL).
This disease is a severely debilitating and potentially life-threatening condition that represents an unmet medical need. Even at the earliest stages of the disease patients suffer from symptoms that have a major, negative impact on quality of life. Existing therapies are often not used early on due to the inherent toxicities. And this new and Promising Innovative Medicine could offer a major advantage over the current treatment options, especially for early stage CTCL patients.
The product has also been designed as an orphan drug at both EMA (European Medicines Agency) and FDA (Food and Drug Administration). And Kinesys Consulting is now helping its US partner with the 2nd stage of the Early Access to Medicines Scheme (EAMS) that will enable patients in the UK to more quickly obtain access to this treatment that could substantially improve their quality of life and potentially their survival expectation.
In addition, this EAMS process enables manufacturers to receive early feedback and advice regarding the promising product’s benefit-risk profile, as well as collect valuable Real-World Evidence (RWE) to better understand the efficacy and safety and to support the Marketing Authorisation Approval.