Category medicine

FDA delays decision on belimumab, and: on the reliability of clinical evidence

One day after my post on belimumab, the FDA announced it would be taking 3 more months to announce its decision on whether to approve it.  A news report cites that the agency wants more time to review the clinical data.  How does this shift the outcome for Benlysta?  It is uncertain.  The regulators could […]

Upholding Standards: Should the FDA approve a new lupus drug with unclear benefits?

If you are one of the estimated 300,000 to 4 million patients in the US who suffer from lupus, you may feel excited about a drug called Benlysta (generically, belimumab).  There is a need for better drugs to treat symptoms, reduce the use of other medications that can have imperiling side effects, and reverse disease progression.  The […]

Upholding Standards: Should the FDA approve a new lupus drug with unclear benefits?

If you are one of the estimated 160,000 300,000 to 4 million patients in the US who suffer from lupus, you may feel excited about a drug called Benlysta (generically, belimumab).  There is a need for better drugs to treat symptoms, reduce the use of other medications that can have imperiling side effects, and reverse […]