Sunday, June 03, 2012

183 diabetes medicines

By Dr. Bill Quick, Health Pro Monday, December 14, 2009


It's fascinating to see that there are four listings for inhaled insulin. Inhaled insulin, under the brand name Exubera, was approved by the FDA in 2006, but was a marketing disaster, and was discontinued by the manufacturer the following year. Around that time, Novo-Nordisk and Eli Lilly discontinued their inhaled insulin programs, but that hasn't stopped other companies from trying.


Inevitably, some of the drugs that are on the list will fail to be approved. At least one, remogliflozin, has been withdrawn by the manufacturer. Two, Galvus (vildagliptin) and Victoza (liraglutide) are under scrutiny by the FDA and may be approved or rejected because of adverse events that the manufacturers reported (skin lesions seen in monkeys for Galvus, and Victoza because of thyroid tumors seen in rodents). Interestingly, both drugs have been approved by European regulators, who set their own standards for what's an acceptable risk.


Speaking of Europe, the listing of 183 medications (plus-or-minus) is stated to be those in development in the United States. There are some diabetes drugs being developed in Europe, which have not yet started trials in the US. So if a global version of the listing were developed, the number would probably be quite a bit higher.


How many of the 183 will be blockbusters, game-changers, or otherwise revise the way we treat diabetes? Hard to say; I'd expect maybe a handful (or a number that could be counted on the fingers of one hand, to mix the metaphor). Some of the 183 will be approved and then fail in the marketplace (like Exubera). Some will be approved then later unexpected side effects will show up. Some will never be approved as studies show lack of efficacy or unacceptable side effects. And some will displace earlier drugs as the new drugs have better efficacy or less side effects than an earlier member of the same drug class.


But it's reassuring to see that the pharmaceutical industry sees diabetes as an area in which to focus its research. Let's hope that this focus on diabetes results in new and better ways to treat diabetes to help all of us.


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By Dr. Bill Quick, Health Pro— Last Modified: 10/11/11, First Published: 12/14/09