FDA say new TB treatment appears safe and effective
The FDA plans to review the Johnson & Johnson-developed drug bedaquiline for accelerated approval. The agency released a review of the product in advance of its formal meeting. Accelerated approval is temporary and based on less clinical evidence that regular approval, according to Fox Business.
The agency's Anti-Infective Drugs Advisory Committee, which is composed of non-FDA medical experts, review will vote on whether or not J&J has provided substantial evidence of the drug's safety and efficacy when it is used as TB treatment in conjunction with other medications.
While safety data for bedaquiline is promising, the panel must examine the overall risk of the medicine's side effects, including the potential for the highest does of the product to cause changes in heart rhythm.
Drug-resistant strains of TB have alarmed public health officials around the world. An FDA review noted current trends in resistance could potentially erode recent gains made against the illness. The concern is likely to help J&J gain early approval, according to FierceBiotech.com.
Bedaquiline was originally developed by Tibotec Group NV , which is now a part of J&J subsidiary Janssen Research and Development.