Amgen spells out FDA's D-mab demands

Amgen has opened up about the FDA delay it faces on denosumab [1], and analysts seem to agree with the biotech's CEO that the company can handle requests for new information without seriously damaging its near-term revenue prospects.

Regulators want Amgen to spell out a formal plan detailing how it will communicate safety issues to patients and doctors, and they want to take a look at updated safety data that Amgen has collected on the blockbuster drug, which will be marketed as Prolia once it gains an approval. The FDA also wants Amgen to mount new clinical trials further investigating the use of the therapy in women with breast cancer--a separate request from the marketing approval it is seeking for the broader population of women with osteoporosis. Researchers will have to demonstrate that denosumab does not spur tumor growth or reduce survival times.

Analysts were encouraged to see evidence that Amgen can get an approval on denosumab  for women with osteoporosis shortly after it satisfies the FDA on safety issues. "It's a bit disappointing that the FDA will require more studies on denosumab breast and prostate cancer, but the treatment-induced bone-loss market is small," Eric Schmidt, an analyst at Cowen & Co., noted to Bloomberg.

- the D-mab info is buried deep in Amgen's release [2] on Q3 results
- check out the story [3] from Bloomberg

Related Articles:
Amgen shares sink as FDA delays D-mab approval [1]
Is Amgen facing a significant delay on denosumab? [4]
Amgen builds a blockbuster case for denosumab [5]
FDA panel backs Amgen's denosumab, limits use [6]