martes, 3 de marzo de 2020

A bedraggled pain drug gets its day at the FDA

The Readout
Damian Garde & Meghana Keshavan

A bedraggled pain drug gets its day at the FDA

There was once a time that so-called NGF inhibitors, drugs that reduced pain without stoking addition, looked like the blockbusters of the future. Then came safety concerns, scientific debates, a few regulatory hiccups, and some significantly reduced expectations.

But one of the NGF therapies, developed by Pfizer and Eli Lilly, made it through that onslaught of setbacks, and now it’s up for FDA approval. The treatment, tanezumab, is under consideration as a treatment for pain stemming from osteoarthritis, and the FDA has promised to give it a yes or no by December.

But the key date will be a few weeks prior, when the agency will convene a panel of external advisors to pore over the evidence and make a recommendation. Many analysts have long since abandoned hope that NGF inhibitors will become a class of useful medicines. The opinion of the FDA’s outside experts will go a long way in teasing out whether they’re right.

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