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FDA fast-tracks Pfizer and Lilly's tanezumab

The novel pain drug treats osteoarthritis and chronic low back pain

Eli Lilly

Pfizer and Eli Lilly have claimed a fast-track designation for their nerve growth factor (NGF) inhibitor tanezumab, a drug vying to become the first alternative to opioid analgesics for severe pain.

The US FDA gave the status to tanezumab as a treatment for osteoarthritis and chronic low back pain in patients who cannot adequate pain relief or cannot tolerate currently available pain medications. The antibody is in a phase III programme looking at bi-monthly subcutaneous injections for both these indications - as well as cancer pain - and is due to generate results in 2018.

Analysts have suggested that a successful NGF inhibitor could be a blockbuster as it would provide an alternative to opioids, which have to be used with care to avoid dependency and unpleasant side effects such as severe constipation.

However the class is littered with discontinued candidates - including AstraZeneca's Medi-578 and AbbVie's ABT-110 - and in 2011 the FDA placed the entire class on clinical hold due to fears that they may cause joint damage and peripheral nervous system side effects.

Pfizer and Lilly have been in a three-horse race to bring the first NGF inhibitor to market. One competitor - Amgen - has been developing its own candidate called fulranumab, but former partners Johnson & Johnson and Takeda handed back rights to the project last year. The drug does not feature in Amgen's pipeline chart.

Meanwhile Pfizer and Lilly's other main rivals in the race to develop NGF inhibitors for pain - Teva and Regeneron - suffered a setback last October when their candidate fasinumab was placed under a clinical hold by the FDA, prompted by a case of joint destruction in its phase IIb trial. Later in the year Regeneron said it was preparing for phase III testing with Teva but there has been no hard news on that programme since.

While tanezumab is still a high-risk programme, the FDA fast-track is a confidence boost for Pfizer and Lilly, and a successful trials programme could deliver a product with blockbuster potential.

They estimate that there are more than 27 million people in the US alone currently living with osteoarthritis and 23 million with chronic low back pain, many of who fail to achieve adequate pain relief despite opioids and other analgesics. Prior to the many clinical setbacks, analysts had predicted NGF inhibitors could become an $11bn drug category.

"We are committed to offering innovative solutions to people suffering from chronic pain conditions, and look forward to working closely with the FDA to facilitate the development of tanezumab," said Christi Shaw, president of Lilly Bio-Medicines.

Article by
Phil Taylor

14th June 2017

From: Regulatory

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