FDA fast-tracks Lilly/Pfizer pain drug amid opioid crisis

Shares in Eli Lilly and Pfizer rose yesterday after the US regulator granted tanezumab a “fast track” designation for patients with osteoarthritis and chronic low back pain.

The FDA is in a hurry to see new non-opioid painkiller drugs reach the market, as an epidemic of addiction to prescription painkillers is sweeping the US.

New FDA commissioner Scott Gottlieb has made finding alternatives to opioids a priority, and Lilly has made great play of tanezumab’s potential as an alternative pain therapy.

However there remains a safety question in connection with the drug:  the anti-nerve growth factor (NGF) inhibitor was delayed for years because of safety fears that emerged during animal studies.

At the end of 2012, the FDA placed development of all NGF inhibitors on clinical hold until manufacturers could demonstrate data showing they did not cause neurological damage over the course of clinical studies.

Pfizer completed three studies and submitted the data to the FDA in February 2015, and the regulator lifted the hold soon afterwards.

With its Fast Track scheme, the FDA expedites development and review of badly-needed drugs that offer significant advantages over available medicines – in this case addressing the need for painkillers without the addictive properties of opioids.

The phase 3 programme is ongoing and includes six studies in 7,000 patients with osteoarthritis, chronic lower back pain, or cancer pain, who do not experience adequate pain relief with approved therapies and results are due next year.

While Eli Lilly and Pfizer have carried on with development of tanezumab into phase 3, the FDA’s cautious approach has hit development of Amgen’s rival NGF inhibitor, fulranumab.

Development partners Janssen and Takeda returned rights to Amgen last year, and the company makes no mention of it on a pipeline round-up published on its website.

And in October last year the FDA called for a halt in development of Teva/Regeneron’s anti-NGF, fasinumab, after a patient developed joint inflammation.

Its main rivals now out of contention, getting tanezumab to market would be a major coup for Lilly and Pfizer, and could provide patients with a badly needed alternative to opioid medication.