ONGLYZA™ (saxagliptin) Receives Marketing Authorisation In Europe For The Treatment Of Type 2 Diabetes

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Published at: www.pipelinereview.com

Fresh Hope for Diabetes Patients

October 15, 2009

Analysis by: GLG Expert Contributor

The success of ONGLYZA (saxagliptin) will largely depend on its long-term safety. Saxagliptin is the second drug from this class to be approved in Europe and the US - Merck's Januvia (sitagliptin) was the first. Saxagliptin has had to overcome several new regulatory hurdles as a result of major recent safety issues with other diabetes drugs including sitagliptin. Sceptical prescribers and heavy postmarketing scrutiny will likely mitigate a rapid uptake.    

Third to market but any advantages?

October 11, 2009

Analysis by: GLG Expert Contributor

With sitagliptin (Januvia, MRK) and vildagliptin (Galvus, NVS) already well established in the European market and the additional availability of the combination of these drugs with metformin, it seems unlikely that saxagliptin (Onglyza, BMS/AZ) will grab much of the market.

Saxagliptin - third gliptin on the EU market

October 8, 2009

Analysis by: GLG Expert Contributor

Besides Sitagliptin and Vildagliptin there will be now a 3rd gliptin available in Europe. Whereas vildagliptin officially needs monitoring of the liver enzymes, at least according to the P.I., and there are new warnings for pancreatitis for sitagliptin no such limitations are known to me at the moment. I do not think that there will be major advantages for saxa compared with sita or vilda, however, we will have to wait and see.