FDA Delays Approval For Roche Arthritis Drug
1 CommentBy Ed Silverman // September 18th, 2008 // 8:41 pm
In a setback for the drugmaker, the agency has issued a ‘complete response’ letter for Actemra, a biologic Roche hopes to market for treating rheumatoid arthritis. An FDA advisory committee endorsed its use last July by a 10-1 vote, but the agency wants “additional documentation” about manufacturing and other unspecified info, some of which relates to final labeling, according to Roche.
The drugmaker, which hopes Actemra will become a billion-dollar seller, maintains the FDA did not request any info involving safety or efficacy issues, and did not require additional studies as a pre-requisite for approval. In a statement, William Burns, who heads Roche’s pharma business, says “we are confident that we will be able to resolve these matters with the agency in the near future.”
Actemra is an anti-interleukin-6 receptor antibody and works differently from the existing class of anti-TNF medicines that block an inflammatory protein called tumour necrosis factor, such aS Enbrel.
Fred Clay
I’d say let the FDA satisfy itself, completely. Examples of drug recalls are aplenty, including that of the infamous drug “Vioxx.” Good to learn that FDA’s concern’s are not about safety in this case, it’s manufacturing and documents. But those are important too. Remember that only recently the FDA in an import alert stated, that it may detain APIs from the Indian drugmaker Ranbaxy due to quality issues. For Roche - “He that can have Patience, can have what he will” Benjamin Franklin - in this case, a “billion-dollars.”