March 8, 2012 by staff
Arthritis Drugs, Some of the world’s largest drugmakers will face an uphill battle next week in their bid to revive a class of experimental arthritis drugs that have been sidelined by safety concerns for nearly two years. The Food and Drug Administration says there is a clear association between the nerve-blocking medications and incidences of joint failure that led the agency to halt studies of the drugs in 2010.
However, the agency also notes that those side effects were less common when the drugs were used at lower doses, potentially leaving the door open for future use. The agency released its safetyanlysis ahead of a public meeting next week where outside experts will discuss the drugs’ safety.
On Monday, Pfizer Inc., Johnson & Johnson and Regeneron Pharmaceuticals will make their case to continue studies of the drugs, with safety precautions to protect patients.
The request to restart testing is unusual, since drugmakers often abandon research on experimental drugs that appear to have safety issues. However, with more than 50 million U.S. adults diagnosed with arthritis – one in five – the potential multibillion dollar market opportunity may be too big to ignore.
If the drugs eventually win FDA approval though, they may be used for much narrower indications than initially envisioned. The FDA’s proposed questions to its experts appear designed to limit any future testing of the drugs.
“Considering what is known thus far about the risks and benefit associated with this class of biologic agents, are there any populations for which further clinical development would be acceptable?” asks one agency discussion question.
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