Cheaper versions of a gout drug that went from nickels to dollars per pill in 2009 because of a Food and Drug Administration program may soon return to the market.
The U.S. Court of Appeals for the Federal Circuit issued an order Jan. 9 that essentially allows West-Ward Pharmaceuticals Corp., an Eatontown, N.J.-based generic-drug manufacturer, to begin selling a new branded version of colchicine.
Takeda Pharmaceuticals USA, which makes the brand-name version of the drug and brought the lawsuit against West-Ward, also announced plans last week to partner with a separate manufacturer to bring generic versions of the treatment to market.
Allowing other manufacturers to market the drug is expected to lower the costs of a therapy that a few years ago cost 10 cents a pill and now costs more than $5 a pill.
The American College of Rheumatology, which filed a brief in support of West-Ward, applauded the news. An ACR spokeswoman said her group expects the price to drop, though pricing details were not immediately available. The ruling “will drive down the cost of colchicine prophylaxis therapy for rheumatology patients nationwide,” the group said.
Colchicine has been used for decades to treat patients with gout and familial Mediterranean fever. It was allowed to be sold without approval from the FDA because it had been on the market before the current approval process existed. An estimated 2% of drugs available in the United States in 2006 were unapproved.
Safety concerns led the FDA in 2006 to create a program encouraging manufacturers to seek regulatory approval of unapproved therapies and to market branded versions. But consumer advocates and medical groups said that in the case of colchicine, the FDA was letting the drugmaker overcharge the public for a drug that's no better or safer than the unapproved form.
An FDA official told Modern Healthcare last year that unapproved colchicine was associated with at least 117 non-overdose deaths, half of which were due to drug interactions.
URL Pharma, a company later acquired by Takeda, won FDA approval in 2009 for branded colchicine, naming it Colcrys. The FDA's later enforcement action against companies marketing unapproved versions of the drug and the exclusivity granted to the manufacturer for the two indications eventually meant that Colcrys was the only version of colchicine on the market.
While clinical trials yield new data about the drug's dosing and efficacy, they also increase its cost. Colchicine's rise from 10 cents to $5 a pill troubled consumers and many doctors.
It appears there will now be three manufacturers of the drug—Takeda; Prasco Laboratories, in a generic partnership with Takeda; and West-Ward—as a result of the order blocking Takeda's motion for a preliminary injunction against West-Ward.
“This new partnership will help enhance patient access to an important gout medicine by supplying Prasco with colchicine tablets manufactured under the same rigorous standards and processes as Colcrys,” said Douglas Cole, president of Takeda Pharmaceuticals USA.
Takeda will continue making the brand-name version of the drug.