NGF Blocker Prospects Enhanced, but Diminished

The unanimous (21-0) vote by a FDA Advisory Committee in favor of allowing continued testing of NGF blockers for osteoarthritis is a welcome acknowledgement that current analgesic options have their own potentially serious–even lethal–adverse event profiles, and that there is a pain population left undertreated by the current options. Pfizer, Regeneron/Sanofi, Abbott, JNJ all have NGF-blocker programs, several arthritis trials have been on clinical hold. Trials–assuming the FDA goes along with the AC, and it is inconceivable that they would not–will not allow combining NGF-blockers with NSAIDs, and will require tracking of bone integrity via imaging during trials. Patients will have to provide detailed informed consent, which allows them to make their own risk-benefit decisions, a welcome alternative (like for Tysabri) to what has at times been in the past a tendency to infantilize patients, as if they had to be protected from their own decision-making. However, if these drugs do complete development and end up commercialized, there will be a ceiling on their use imposed by both this risk profile (and probable need for monitoring) and the high cost-premium that will be exacted compared to generic options. Tysabri in MS eventually became successful, though not to the extent originally predicted, and it remains alone in its class. With multiple NGF-blockers sharing what will be an attenuated degree of market-access, the path for any of them to blockbuster status is going to be much more difficult than had been projected a couple of years ago.

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