IHS Global Insight Perspective | |
Significance | AstraZeneca and BMS's co-development Type 2 diabetes drug Onglyza has been shown to be as effective as Merck and Co's Januvia, and has become the first ever DPP4 inhibitor to be approved in Europe. |
Implications | This news comes as no surprise following the earlier positive recommendation by the EMEA. Onglyza will shortly be launched in all 27 EU countries. |
Outlook | Due to their similar clinical profile, Onglyza and Januvia are set to go head-to-head for market share in the United States, and also in the EU, where Januvia is awaiting final approval following a positive recommendation by the EMEA last week. The market for Type 2 diabetes treatments is set to become increasingly crowded, with numerous pipeline products said to be in development. However, following its early marketing approval on both sides of the Atlantic, Onglyza is set to become an important revenue earner for AstraZeneca and BMS. |
EU Marketing Approval for Onglyza
Onglyza (saxagliptin), the Type 2 diabetes drug co-developed by AstraZeneca (U.K.) and Bristol-Myers Squibb (BMS; U.S.) has gained marketing approval from the European Commission, having been granted a positive recommendation by the European Medicines Agency's (EMEA's) Committee for Medicinal Products for Human Use (CHMP), as well as receiving U.S. FDA approval earlier this year (see United Kingdom: 26 June 2009: AstraZeneca, BMS Granted Positive European Recommendation for Diabetes Drug Onglyza and United Kingdom: 3 August 2009: FDA Grants Approval to AstraZeneca and BMS' Onglyza). As a result, the drug, which is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated as an adjunct to diet and exercise in order to improve blood sugar in adults with Type 2 diabetes mellitus, will now be available for sale in all 27 member states of the European Union (EU). It will be used in combination with traditional diabetes treatments such as metformin, thiazolidinedione, or sulphonylurea.
Onglyza as Effective as Januvia
As part of its application for marketing authorisation to the EMEA, AstraZeneca and BMS submitted data from an 18-week head-to-head clinical study comparing Onglyza in combination with metformin with U.S. firm Merck & Co's rival drug Januvia (sitagliptin) in combination with metformin. The results of the study showed that Onglyza was as effective as Januvia in reducing blood-sugar levels in the patient population, with similar side effects recorded. The study involved 801 adults with Type 2 diabetes aged 22–87, and the full results will be published in 2010.
Outlook and Implications
Onglyza and Januvia, which are both in a new class of diabetes treatments, are set to go head-to-head in a fight for market share. Both drugs are already approved for use in the United States, and are currently the only recommended DPP4 inhibitors. This EU approval for Onglyza will be a boost for AstraZeneca and BMS, as it makes the drug the first ever approved DPP4 inhibitor in Europe, having lost the race to Januvia in the U.S. market. As a result, the two companies have announced that they intend to launch the drug as early as the fourth quarter of this year. However, rival product Januvia is already close on its heels, having gained a positive recommendation from the EMEA in the last few days, with final approval expected shortly (see United States: 28 September 2009: CHMP Recommends Merck's Januvia, Janumet for EU Approval). The news of clinical trails that have shown that both drugs display similar clinical efficacy will also boost Onglyza, especially in the United States, where it was second to market. However, if AstraZeneca and BMS want to win the race for market share against Januvia, they need to continue to pursue their current comprehensive clinical development programme to better differentiate their drug. In addition to Januvia, there are also other competitor products that they need to keep an eye out for. These include other DPP4 inhibitor drugs such as Swiss pharma Novartis's Galvus (vildagliptin), and Japanese firm Takeda's alogliptin, which is currently subject to regulatory delays. Due to the market need for innovative diabetes products, there are up to 30 companies who are currently developing DPP4 inhibitor treatments; it is therefore important that AstraZeneca and BMS establish themselves as leaders in the market for diabetes drugs before the area becomes overcrowded. The diabetes treatment area is a lucrative one, with an estimated 246 million people suffering from diabetes—mostly Type 2. Type 2 diabetes is mainly attributed to lifestyle issues such as poor diet and insufficient physical activity, and this number is therefore set to grow due to increased westernisation linked to economic development, especially in transition economies. Both Onglyza and Januvia have already reported sales of US$1.4 billion in 2008 alone, and despite the competition, Onglyza is set to become an important revenue earner for AstraZeneca and BMS.