So Pfizer & Lilly do ask FDA to approve Tanezumab for OA pain...
Just a few months ago some commentators had pronounced the death of Tanezumab and the whole anti-NGF class it leads, following years of development issues trying to establish a safety margin in OA patients.
However, in the recent Pfizer Q4 earning's call (actually within the Q&A's) it was confirmed that the submission for Tanezumab to the FDA had been completed in December - Exert and link below.
Angela Hwang -- Group President, Pfizer Biopharmaceuticals Group
Right. And then your second question was on tanezumab. So we're really pleased that in December of 2019, we completed our US submission of tanezumab, and we are also pursuing regulatory submissions in the EU and in Japan. This submission was done in close collaboration with the FDA, and it includes the 2.5 milligram in moderate to severe osteoarthritis patients. So, at this moment in time we're awaiting acceptance of this filing. But we see significant potential of tanezumab in osteoarthritis. So we're really excited about this filing, particularly because we're in a time where non-opioid solutions are very, very much needed for these patients.
If you look at the market potential, today, there are about 27 million Americans that suffer from osteoarthritis and 11 million of those have moderate to severe OA. 80% of those 11 million people have tried and failed three or more analgesics. So that tells us that there is just a huge amount of unmet need in this patient population. Patients are cycling through a number of pain medications and there just is an incredible need for new options and this is where we think tanezumab can really fill an unmet need. It has the potential to become the first-in-class non-opioid treatment for these patients and we eagerly await the acceptance of this file from the FDA.
It was around 10 years ago that the first data demonstrating ‘amazing’ analgesic efficacy in OA was published for Tanezumab - a monoclonal antibody against nerve growth factor. Tanezumab, discovered and developed by Rinat Neuroscience and acquired by Pfizer in 2006, was hailed as the new ‘wonder drug’ for pain that was set to become a major blockbuster disrupting the analgesic field.
Since then it has been a somewhat tumultuous development path for the whole anti-NGF class with an FDA clinical hold in 2012 which was eventually reversed in 2015. Links between NGF blockade and dangerous changes to the nervous system and joint destruction caused these concerns and finding a balance between safety and efficacy has been the key goal ever since. However, in 2017 the FDA gave a signal of confidence in Tanezumab when it received Fast Track designation and it was also given a boost back in 2013 when Eli Lilly announced a $1.8B deal to partner with Pfizer despite of the clinical hold.
The first data in OA were indeed very impressive (https://www.nejm.org/doi/full/10.1056/NEJMoa0901510) and it is interesting to note that first data set included doses from 10 – 200 μg/kg (https://www.nejm.org/doi/full/10.1056/NEJMoa0901510). The very latest clinical data for OA (https://www.businesswire.com/news/home/20190418005771/en/) now use only the lower doses of just 5 and 2.5mg and the higher dose produced significant efficacy but rapidly progressive osteoarthritis. Thus, the efficacy levels now seen are really nothing like those first reported with the higher doses.
With only the 2.5mg dose asked to be approved Tanezumab will likely only treat a small subpopulation of the OA patients rather than becoming the blockbuster broad analgesic that had been first hoped for.
Clearly there is still lots of analgesic innovation required to find new treatments for the 1 in 4 of us suffering chronic pain,