This is a blow to Roche, but a respite for Amgen. The FDA stopped short of approving Roche’s Mircera anemia med for treating patients with kidney disease. Outright approval won’t happen until at least the fall, when the agency holds a safety meeting on anemia drugs.

The Swiss drugmaker now say it expects the medicine’s label to be finalized after an FDA panel issues recommendations on the entire Epo class of anemia drugs now under scrutiny because of concerns about safety and their potential overuse. These include Amgen’s Epogen and Aranesp, and Johnson & Johnson’s Procrit.

“We are confident that Mircera will be approved in the United States and we understand and support the FDA’s initiative to convene an advisory panel to review the use of anemia agents in the renal setting,” says a disappointed George Abercrombie, Roche’s US ceo.

Amgen has been fighting the Roche drug on several legal and regulatory fronts, alleging it infringes Amgen patents. Roche argues its drug is different, claiming Mircera is longer lasting than other available anemia drugs.

An FDA panel of cancer experts reviewed the use of the drugs in oncology patients this month and made several recommendations that would restrict their use, sparking a steep decline in Amgen’s share price. The Mircera delay, naturally, will be viewed as a positive for Amgen.

Further reading…
Associated Press;
CNNMoney.com;
[tags]Amgen, Aranesp, Epogen, Mircera, Procrit, Roche[/tags]