Astrazeneca boosted by US diabetes recommendation

LONDON (ShareCast) - Astrazeneca (NYSE: AZN - news) gave US regulatory updates on two pipeline products, with an encouraging review for a pair of diabetes treatments and granting of 'orphan drug' status for a cancer treatment that should ease its path to marketing approval. A pair of drug combinations to treat type-2 diabetes were, after the a review of trial results, deemed by an advisory committee to the US Food & Drug Administration (FDA) to have an acceptable cardiac risk profile but that the drugs should carry extra safety information on their labelling.

One member of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted to withdraw the saxagliptin treatment from the market due to an increased risk of hospitalisation for heart failure for some patients found in the trial results, but the 14 other members were content to recommended additional labeling was sufficient.

AstraZeneca said it will conduct further investigation to better understand the signals leading to heart failure.

The FDA is is not bound by the advisory committee's recommendation but does takes its advice into consideration when reviewing drug applications.

Meanwhile, the FTSE 100 group's tremelimumab treatment for a rare and aggressive form of cancer was granted with the special 'orphan drug' status by the FDA, which should see the product more easily gain full regulatory approval.

The orphan status has been granted for tremelimumab's use to treat mesothelioma, a rare and aggressive cancer often affecting the lungs and abdomen and with very few other treatment options. The drug is also separately being investigated as a treatment for tumours including lung cancer and head and neck cancer.

"There is a significant need for new treatment options for patients with mesothelioma because fewer than five percent of patients currently survive beyond five years, even when they receive timely diagnosis and care," said the company's immuno-oncology chief, Robert Iannone.

"Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients."