The US Food and Drug Administration (FDA) has approved the first generic of Daraprim, a decades-old drug for the treatment of toxoplasmosis that hit the headlines in 2015 after its price rocketed from $13.50 per tablet to $750 overnight.
It’s taken five years, but the US regulator has finally followed through on a pledge to get an alternative generic on the market, after giving a green light to Cerovene’s version of Daraprim (pyrimethamine).
The 5,000% price rise for Daraprim – just after it was acquired by Turing Pharmaceuticals – was the catalyst for a public outcry over avaricious medicine price increases in the US, and threw Turing’s then chief executive Martin Shkreli into the spotlight.
The approval means Turing – since called Vyera Pharma and then Phoenixus – no longer has a monopoly on the off-patent drug, used to treat an opportunistic and serious parasitic infection that is generally seen in people with weakened immune systems, including those with uncontrolled HIV.
Shkreli – who he is currently serving a seven-year prison sentence for securities fraud – retains a controlling stake in Switzerland-based Phoenixus and is allegedly running the company from his mobile, according to media reports.
Phoenixus has resisted pressure to lower the price of the drug, and is reportedly haemorrhaging cash – a situation which will presumably only get worse once the generic is available. Shkreli’s official release date is in October 2023.
Cerovene, which is best known as a contract developer and manufacturer of generic drugs for other companies, hasn’t revealed yet what its pricing and commercialisation plans are for the generic pyrimethamine product.
The generic has been approved under an accelerated review system set up by the FDA in 2016 to speed up the review of marketing applications for generic versions of drugs that exploit a monopoly position.
“Through the FDA’s Drug Competition Action Plan, we’ve worked to remove barriers in generic drug development…by closing loopholes that allow brand-name drug companies to ‘game’ the rules in ways that delay generic competition,” said FDA commissioner Stephen Hahn.
Gaming tactics include preventing generic drugmakers getting samples of a brand-name drug to carry out comparative studies in support of a marketing application. The FDA published a list of all the drugs which generic drugmakers claim have been subject to that sort of restriction, and Daraprim is on it.
The approval of Cerovene’s drug “is especially important for populations that are more susceptible to toxoplasmosis infections, such as pregnant women and individuals with HIV or AIDS by paving the way for more choices in treatment options.”
Other attempts to break the Daraprim monopoly included pharmacy benefit manager (PBM) Express Scripts forging a partnership with compounding pharmacy company Imprimis to provide a low-cost alternative.