Amgen anaemia treatment worries FDA

Source: Healthcare Digital

Date :12/03/2008 06:42:52

US-based pharmaceutical company Amgen is waiting on an FDA ruling later this week to determine the outcome of its new anaemia drug, Aranesp.

The outlook for Amgen’s drug – aimed at cancer chemotherapy patients – appears bleak as the FDA pointed to eight studies showing evidence of harmful side-effects including shorter survival times and accelerated tumor growth.

The panel will also assess rival drug company Johnson & Johnson’s Procrit, exploring the net benefits of these treatments of anaemia in cancer and kidney patients.

Early indicators all suggest a setback for both companies, as the evidence against both drugs continues to grow. Despite this, both companies contest that the benefits far outweigh the risks when used for treating chemotherapy patients.

“They provide an important clinical option for some patients,” said Amgen in a statement.

Scepticism

Should the ruling go against the drug companies – as is expected – Amgen is likely to suffer more than Johnson & Johnson, having placed a greater stake in its Aranesp drug.

Sales for the drug in 2007 hit $3.6 billion, with the company seeing its market capitalization plunge by more than $28 billion.

Amgen shareholders are sceptical about the product, shares in the company falling 1.3 percent on Nasdaq as trading closed yesterday.

March 12, 2008