A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).
Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.
The REMS for Avandia dates back to 2010, when the FDA began moving to severely restrict its marketing, based on a 2007 study linking it to heart attacks, and amid allegations that GSK continued marketing the drug despite being aware of its cardiovascular risk, for which the drug maker paid the U.S. Attorney's Office for the District of Colorado $3.4 billion. Approved by the FDA in 1999, U.S. sales of Avandia and related drugs such as Avandamet (rosiglitazone; metformin hydrochloride) reached $1.86 billion by 2006, achieving a diabetes market share of 37%, according to GSK. But by 2009, that figure had fallen to $660.4 million. And by 2012, global sales were $9.3 million. Teva is approved to make the only generic version of Avandia, under a patent-litigation settlement reached with GSK in 2007, but it hasn't launched the drug.
In other words, what was once among the world's top diabetes drugs suffered from a restrictive REMS, but it still faces limited generic competition, meaning that it could see sales pick up if the FDA decides to ease the restrictions on it and allow it to be dispensed in environments such as retail pharmacies — though it's unlikely to ever achieve the sales it did early on given the controversy surrounding it; even the New York Times called the FDA advisory committee's vote a "minor victory" for the drug.
Also, in addition to Takeda's Actos and nearly a dozen generic versions of that drug, there were 130 drugs under development for Type 2 diabetes last year, according to the Pharmaceutical Research and Manufacturers of America, out of 221 under development for diabetes overall; of the 221, 53 were in late-stage development or under FDA review. Many of the drugs under development include pioglitazone, the active ingredient in Actos, and one, Kalamazoo, Mich.-based Metabolic Solutions Development's MSDC-0160 (mitoglitazone) belongs to the same class as Actos and Avandia.