FDA OKs wearable injector for Amgen’s Repatha cholesterol drug
The U.S. Food and Drug Administration approved a new type of injector for Amgen’s cholesterol reducing drug Repatha on July 11.
The FDA approved a wearable injector, called the “Pushtronex” system, that sticks to patients’ bodies and delivers a dose of the drug monthly under the skin. Patients can perform moderate physical activities like walking or bending while the treatment is applied.
The FDA approved Repatha last August, but the drug has been criticized for its high cost. Treatments cost about $14,000 per year, even though the Institute for Clinical and Economic Review found Repatha would be cost effective at just $2,177 per year. The drug is a form of drug called a PCSK9 inhibitor, which block a protein and lowers cholesterol levels in the blood.
In March, Amgen won a lawsuit filed against Regeneron Pharmaceuticals and Sanofi for violating Repatha patents. In October 2014, Amgen sued Paris-based Sanofi and Tarrytown, N.Y.-based Regeneron for violating patents for Repatha after Sanofi and Regeneron co-developed PSK9 inhibitor Praluent to treat high cholesterol in adults.
Sales of Repatha were $16 million during the first quarter.
• Contact Philip Joens at [email protected].
