Teva and Regeneron see medical study put on hold due to safety concerns
Drug development partners Teva and Regeneron have had a major study halted by regulators due to concerns being raised about the safety of the trial.
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The anti-NGF fasinumab drug has been placed in a clinical hold, according to the Food and Drug Administration (FDA). It is being tested as a treatment for lower back pain caused by the likes of osteoarthritis.
As a result of the decision, Regeneron has stopped testing the drug on patients and will conduct a review of the procedures used thus far.
"We are making data-driven decisions on Phase III fasinumab dosing that we believe will maximize potential benefit for patients in need, while minimizing the likelihood of side effects,” said George Yancopoulos, chief scientific officer at Regeneron.
While accepting the decision of the FDA, Teva said that it still retained its full confidence in the effectiveness of the drug.
"We believe fasinumab represents an important potential innovation for patients with osteoarthritis pain and chronic low back pain who currently have clear unmet need and limited treatment options," said Teva's Michael Hayden.
Other established pharmaceutical companies Lilly and Pfizer have also been working on their own version of anti-NGF drug, tanezumab.
It has been said that effective treatment for osteoarthritis which does not use opioids could be a multibillion dollar market opportunity.