FDA approves first generic version of Shkreli-hiked toxoplasmosis drug Daraprim

pharmafile | March 2, 2020 | News story | Sales and Marketing Cerovene, Daraprim, FDA, Martin Shkreli, generics, pharma 

The FDA has awarded approval to the first generic medicine for the treatment of toxoplasmosis, authorising Cerovene’s version of Daraprim (pyrimethamine) for the indication when combined with sulphonamide.

Daraprim was dragged into the public eye in 2015 when infamous “pharma bro” Martin Shkreli acquired it via his firm Turing Pharmaceuticals (now known as Vyera Pharmaceuticals) and hiked its price from $13.50 to $750 per pill, an increase of more than 5,000%.

Shkreli eventually went to prison for securities fraud, but went unpunished for the actual hiking of the drug’s price. This new approval comes five years after the original price debacle and aims to provide patients with an affordable alternative treatment for the condition after decades on the market with no generic competition.

Toxoplasmosis is caused by the parasite toxoplasma gondii, with infections usually originating from contaminated meat, shellfish or water. Severe infection can cause organ damage, particularly of the brain or eyes. Those who are immunocompromised, such as HIV or AIDS patients, are especially susceptible to severe forms of the condition.

“The FDA has a longstanding commitment to increasing competition in markets with limited or no generic alternatives,” explained  FDA Commissioner Dr Stephen M Hahn. “Through the FDA’s Drug Competition Action Plan, we’ve worked to remove barriers in generic drug development by not only taking actions that improve the efficiency of the development, review and approval of generic drugs, but also by closing loopholes that allow brand-name drug companies to ‘game’ the rules in ways that delay generic competition that Congress intended.

“Empowering patients and promoting choice and competition are top priorities for the FDA. These important efforts include improving access to safe, effective and high-quality generic medications. Today’s approval 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.”

Matt Fellows

Related Content

FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis

Nexcella has announced that the US Food and Drug Administration (FDA) has granted orphan drug …

GSK’s Ojjaara approved by FDA for patients with myelofibrosis and anaemia

GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) …

Madrigal Pharmaceuticals’ NDA for resmetirom accepted by FDA

Madrigal Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted for …

Latest content