FDA approves first new drug for lupus in 56 years
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Rating
FDA approves first new drug for lupus in 56 years
Our Review Summary
Good caveats, including in the patient profiled, who said, "It’s a bittersweet thing for me because I have friends with lupus for whom this drug won’t work. There’s no one-size-fits-all for lupus and I’m just extremely fortunate that my lupus is mild and is helped by Benlysta."
The story should have discussed potential harms and costs.
Why This Matters
As the story explained, this was not only the first new lupus drug approved in 56 years, but it could be "a milestone that medical experts say could prompt development of other drugs that are even more effective in treating the debilitating immune system disorder."
Criteria
Not Satisfactory
The cost of the drug wasn’t mentioned – a big oversight. Other news stories pegged it at about $35,000 a year.
Satisfactory
Adequate job. The story explained: "But experts stress that Benlysta is not a miracle drug: It only worked in 35 percent of North American patients tested and was not effective for patients with the deadliest form of the disease. Additionally, it did not show positive results in African Americans, who are disproportionately affected by lupus."
Not Satisfactory
There was no discussion of harms. An NPR story, by comparison, pointed out that "There are side effects, of course, and some of them are pretty serious. In clinical tests involving about 2,100 people, 11 taking Benlysta died compared with 4 getting placebo. About 6 percent of people taking Benlysta got serious infections compared with 5.2 percent on placebo."
Satisfactory
The story offered an interesting historical perspective on the evidence: "The company originally tested Benlysta, known generically as belimumab, as a treatment for rheumatoid arthritis. When a mid-stage trial in lupus patients failed to meet researchers’ goals in 2006, many analysts wrote the drug off and downgraded the company’s stock. But when scientists reanalyzed the data they found that the drug helped block the antibodies that cause lupus symptoms in a subset of patients."
Satisfactory
No disease mongering of lupus.
Satisfactory
Two independent sources were quoted.
Not Applicable
Not applicable. With no other new drug approved for lupus in 56 years, there’s not been much to compare it with. The story did state that some experts thought this "could prompt development of other drugs that are even more effective in treating the debilitating immune system disorder."
Satisfactory
The focus of the story is FDA approval of the new drug.
Satisfactory
The headline explains that the FDA approved the first new drug for lupus in 56 years.
Satisfactory
It’s clear the story did not rely solely on a news release.
Total Score: 7 of 9 Satisfactory
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