R&D

Dogged by safety issues, Eli Lilly and Pfizer tout their latest PhIII for anti-NGF pain drug tanezumab

Scientists at Eli Lilly and Pfizer have racked up a fresh set of positive efficacy numbers for their closely-watched anti-NGF pain drug tanezumab. But once again they have been dogged by safety issues that have blighted the class.

The researchers noted that the high 10 mg dose of tanezumab scored a statistically significant win on chronic lower back pain, while the 5 mg dose fell short of the bar. We don’t know how well the top dose group performed though, as the team is holding back the data set for a conference.

Pooling the safety data, rather than breaking it out by dose, the team also reported that 1.4% of the patients taking the drug experienced rapidly progressive osteoarthritis, compared to 0.1% in the control arm. There were no signs of osteonecrosis in either group.

Efficacy was tracked for 16 weeks for the primary endpoint, while patients were observed for 80 weeks. Ken Verburg, tanezumab development team leader at Pfizer, called it one of the longest pain studies ever done.

But once again, lingering questions about the drug’s longterm safety remain — a subject that forced a range of drugs onto the shelf for several years. And that’s a troubling sign for a drug intended for a mass audience of people suffering from chronic pain.

Eli Lilly stepped up with a deal worth up to $1.8 billion to buy into this drug, despite the troubles it’s had. Teva and Regeneron had to back off their two high doses for fasinumab, a rival therapy. And Pfizer stepped down from 20 mg to 10 mg for the high dose, spurring questions about just how effective this drug can be.

J&J, meanwhile, dropped fulranumab more than 2 years ago. AstraZeneca abandoned its Medi-578 candidate in 2010 and AbbVie has also dropped another NGF blocker called ABT-110.

Eli Lilly and Pfizer have two more Phase III studies to report out this year.


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