AstraZeneca and Bristol-Myers Squibb have been told by the US Food and Drug Administration that has pushed back its decision date on their new diabetes drug Onglyza.

The agency says it needs additional time to complete the review of the New Drug Application for Onglyza (saxagliptin) so has extended the Prescription Drug User Fee Act date from next Thursday to July 30. The NDA for the dipeptidyl peptidase-4 inhibitor was submitted in June last year.

It does not seem that AstraZeneca and B-MS will need to provide any additional information on the drug which earlier this month received a positive recommendation from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee. The panel voted (by 10 to 2) that the data supporting the NDA were sufficient to rule out “unacceptable cardiovascular risk relative to comparators”.

Analysts at Deutsche Bank do not seem too concerned about the delay and noted that a number of diabetes drugs have been delayed due to a heavy workload at the FDA. Simon Mather at WestLB issued a research note noting that the delay was not a surprise, given that a trial is underway in patients on Onglyza with renal impairment to rule out the possibility of skin-related side effects. The latter problem led to the FDA issuing only an approvable letter for Novartis’ DPP-4 drug Galvus (vildagliptin) a couple of years ago.

If approved, Onglyza would compete with Merck's DPP-4 inhibitor Januvia (sitagliptin), which is well-established on the market. Analysts have given a wide range of sales estimates for the drug, saying they could go from $300 million to $2 billion.

CHMP positive over Iressa
Meantime AstraZeneca also noted that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on its almost-forgotten oral anti-cancer drug, Iressa (gefitinib).

Specifically, the CHMP has recommended the approval of the drug for adults with locally advanced non-small cell lung cancer with activating mutations of epidermal growth factor receptor-tyrosine kinase. The positive opinion is based on a submission package that includes two Phase III studies, IPASS and INTEREST.

Anders Ekblom, executive vice president for development at AstraZeneca, said the positive CHMP opinion “is an important step towards addressing the great unmet medical need of lung cancer patients in Europe, and supports AstraZeneca’s personalised healthcare strategy to develop the right medicine for the right patient”. If Iressa is approved, “for the first time patients with these types of EGFR positive tumours will have a better alternative to chemotherapy as a first-line treatment”, he added.

The company will be required to conduct a follow-up measure study, to generate further data in a Caucasian NSCLC patient population, and it is in discussion with the CHMP to finalise the study design and endpoints.

The news represents a return to the spotlight for Iressa, which is sold in the Asia-Pacific region and was previously touted as a blockbuster. However those hopes collapsed in 2004 when results from a 1,700-patient study in people with advanced NSCLC who had failed on previous chemotherapy revealed that at the end of one year, just 27% of the Iressa group were still alive compared to 21% of placebo receivers.

AstraZeneca was allowed to keep the drug on the market in the USA, but its use was heavily restricted and no new patients were allowed access to the therapy unless they were taking part in a clinical trial. The firm withdrew its application to market Iressa in Europe shortly after.

If Iressa gets approved in Europe, it will compete with Roche/OSI Pharmaceuticals’ blockbuster Tarceva (erlotinib).