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FDA Approves New Diabetes Drug Onglyza

On July 31, the FDA approved Onglyza, and the drug is now available on pharmacy shelves. Onglyza is a DPP-4 inhibitor, the same class of drug as Merck’s Januvia. It is designed to be taken once a day by patients with type 2 diabetes. We were excited to see Onglyza approved in the US because it is one of the first drugs to successfully pass some of the FDA’s new, stricter rules for diabetes drugs about cardiovascular disease and cardiovascular events. (See our story on this evolution here) This means that so far it has not been associated with increased risk of cardiovascular events, but the FDA is requiring the sponsoring company to conduct trials after it is put on the market to confirm this is true. This will add about $50-$100 million to development costs by our estimates. The drug prevents a particular hormone (called GLP-1) from being broken down inside the body, which helps control glucose levels. The DPP-4 inhibitor class is known to be very tolerable and to have very few side effects, though a small percentage of patients taking the drug experienced upper respiratory tract infections, urinary tract infections, headache, rashes and hives. This class of drugs, which includes Merck’s Januvia and Janumet (approved in dozens of countries globally) and Novartis’ Galvus (approved outside the US), has been commercially successful, beyond virtually all initial expectations. We think that is because the drugs are easy to prescribe (few side effects prompt few phone calls) and easy to take (once daily, few side effects) – in today’s market, drugs and devices that sell well must have positive outcomes, no serious safety problems, and are usually associated with simplicity and little hassle.

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