The chances of AstraZeneca and Bristol-Myers Squibb’s investigational diabetes compound Onglyza getting on the market to compete with Merck & Co’s Januvia have improved following a generally positive response from a US advisory panel.
The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee have decided (by a vote of 10 to 2) that the data supporting the New Drug Application for Onglyza (saxagliptin) were sufficient to rule out “unacceptable cardiovascular risk relative to comparators in the programme”. The panel did review the overall safety and effectiveness of the drug, which is a dipeptidyl peptidase-4 inhibitor.
However the committee also unanimously recommended that AstraZeneca and B-MS perform a post-marketing trial to confirm the cardiovascular profile of Onglyza. The firms are working on a series of Phase IIIb and IV studies and say they will now work with the FDA to finalise the post-marketing trial designs.
The data package submitted by the companies involved more than 5,000 people, more than 4,000 of whom were given Onglyza, and safety and efficacy results from six Phase III trials.
However several panellists expressed concern that, if approved, the FDA should require information on the drug’s label, noting the lack of information that is available for patients who already suffer from chronic heart disease. The FDA will consider the panel’s recommendation and is expected to make a decision by April 30.
If approved, the drug 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 Onglyza, saying they could go from $300 million to $2 billion.
Investors are pleased with the panel’s recommendations and at 10.15 this morning (UK time), AstraZeneca shares were up 2.3% to £24.79.
