Kinesys Consulting has secured its first PIM designation, for a novel oncology supportive care product, on behalf of a US partner. The product, designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA), is being developed for the treatment of Severe Oral Mucositis in Head & Neck Cancer patients, a population of very sick patients who have no other available medical therapy, and whose oral mucositis often leads to interruption or postponement of essential chemoradiation. The product has the potential to be a game-changing treatment in this condition of very high unmet medical need.
The PIM procedure (Step 1) was rapid and interactive. The review and decision by the MHRA Scientific Committee, following the recommendation by the assessors, took less than 2 months in total, and only 2 – 3 weeks after the very collaborative PIM meeting with MHRA assessors.
The interaction between Kinesys, our US partner and the MHRA during the procedure, and especially the face-to-face meeting, were very positive and helpful. This opportunity to engage in an early Regulatory and Market Access dialogue with the MHRA and NICE (also Scottish Medicines Consortium) can truly help in the optimisation of the development programme to support an expedited review process, enabling earlier patient access in the UK.
Successful PIM designation is the first step towards, and confirmation that, the medicinal product is a potentially suitable candidate for the Early Access to Medicines Scheme (EAMS). The Applicant can subsequently proceed to the 2nd stage, which is the EAMS Scientific Opinion assessment step. At this stage, there is the opportunity to engage with both the MHRA and NICE and receive a recommendation on the suitability of the product to proceed to Scientific Opinion based on the data package at the current stage of development. Following a positive EAMS scientific opinion, MHRA will publish a Public Assessment Report (PAR) and the EAMS treatment protocol. This will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.
Kinesys and its partner look forward to making this Promising Innovative Medicine available to UK patients in the near future.
Find out more about the Early Access to Medicines Scheme (EAMS) here