A drug that's been on the market for decades and is commonly used to treat gout may once again return to the U.S. market with a cheaper price.
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 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 this week to partner with a separate manufacturer to bring generic versions of the treatment to market.
Allowing generic manufacturers to market the drug is expected to lower the costs of a therapy that only a decade ago cost 10 cents per pill and now costs more than $5 per pill.
The American College of Rheumatology, which filed a brief in support of West-Ward, applauded the news. A spokeswoman said the organization expects the price of the drug to drop although pricing details were not immediately available.
“The ACR is pleased that it was able to play an important role in the reintroduction of competition to the colchicine market, which will drive down the cost of colchicine prophylaxis therapy for rheumatology patients nationwide,” the organization said.
Colchicine has been used by the medical community for decades to treat people with gout as well as patients with familial Mediterranean fever. It was allowed to be sold without approval from the Food and Drug Administration because it had been on the market before the current approval process existed. An estimated 2% of drugs available in the U.S. in 2006 were unapproved.
Safety concerns about these drugs led to the creation in 2006 of an FDA program that encouraged manufacturers to gain regulatory approval of unapproved therapies. Unapproved colchicine was associated with at least 117 non-overdose deaths, half of which were due to drug interactions, Kalah Auchincloss, acting director of the FDA's Office of Unapproved Drugs and Labeling Compliance, told Modern Healthcare last year.
URL Pharma, a company later acquired by Takeda, received 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 company for the two indications eventually meant that Colcrys was the only available version of colchicine on the market.
While clinical trials yield new data about the drug's dosing and efficacy, going through the approval process led the company to increase the cost of the drug. Colchicine's rise from 10 cents to $5 a pill troubled consumers who saw the price of their prescriptions rapidly increase.
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 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, as well.
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