The FDA approved yesterday a generic glimepiride tablet, manufactured by Ranbaxy, that will compete with Sanofi-Aventis’s Amaryl. The generic will be offered in three additional dosages—4 mg, 6 mg, and 8 mg—in addition to those already available in Amaryl (1 mg, 2 mg, and 3 mg). Sanofi-Aventis also mentioned at its August 31 investor meeting (see our comments on that meeting from our blog on date X) that it will look into marketing their own generic glimepiride, though we haven’t heard much more on this front as of yet. The expiration of the patent will be a net negative for Sanofi, since Amaryl sales broke $1 billion in 2004. We expect their marketing strategy with type 2 patients to change to reflect both the loss of Amaryl sales and the introduction of their new rapid-acting insulin glulisine, Apidra. Apidra - finally! - is starting to be more widely available in pharmacies and promises a quick onset and shorter duration of action. It is pen only, which is why the delay in launch, given the April 2004 approval. Sanofi used to target (at least unofficially) type 2s with a “one shot a day, one pill a day (Lantus and Amaryl)” campaign—we are fascinated to see how the message will change, given that Apidra before meals is way more complicated than one Amaryl pill a day. We've heard that some type 2s have actually been overdosing Lantus in order to make up for absence of prandial insulin (previously only Humalog and Novalog were available) - will be interesting to see how much more prandial insulin grows as a class with this new entry. Some may recall that for awhile, it was thought that Apidra had some sort of beta cell regeneration qualities - that hasn't been raised in awhile, and we're not sure about the quick onset, but we'll both (Kelly and Erin here) look forward to testing it! What we're really interested to see if one of the insulin manufacturers (Lilly would be the logical one obviously due to its partnership with Amylin, but since no one is linked with Amylin on Symlin, who knows?) could possibly do a rapid acting analog/Symlin mix. We aren't sure if this is possible due to pH etc but wow how fantastic!
On that note! We've heard pump sales have seen an uptick in the (admittedly still small but growing) set of patients going on Symlin.
We've also heard that some patients are actually returning to regular insulin because it has a longer duration of action, which is sometimes helpful for some taking Symlin. Personally we'd never do it, easier just to pump or take a quick pen bolus in our view ~
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